# EUR-Lex - 52012PC0008 - EN

*|*

# 52012PC0008

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the classification, packaging and labelling of dangerous preparations /* COM/2012/08 final - 2012/0007 (COD) */**

			*

			*

EXPLANATORY MEMORANDUM

1.           On 1 April 1987 the
Commission decided[1]
to instruct its staff that all acts should be codified after no more
than ten amendments, stressing that this is a minimum requirement and that
departments should endeavour to codify at even shorter intervals the texts for
which they are responsible, to ensure that their provisions are clear and
readily understandable.

2.           The codification of
Directive 1999/45/EC of the European Parliament and of the Council of 31 May
1999 concerning the approximation of the laws, regulations and administrative
provisions of the Member States relating to the classification, packaging and
labelling of dangerous preparations[2]
has been initiated by the Commission. The new Directive was to have
superseded the various acts incorporated in it[3].

3.           In the meantime the Lisbon Treaty
entered into force. Article 290 of the Treaty on the Functioning of the
European Union (TFEU) allows the legislator to delegate to the Commission the
power to adopt non-legislative acts of general application to supplement or
amend certain non-essential elements of a legislative act. Acts adopted by the
Commission in this way are referred to in the terminology used by the TFEU as
"delegated acts" (Article 290(3)).

4.           Directive 1999/45/EC contains
a provision with regard to which such a delegation of power would be opportune.
It is therefore appropriate to transform the codification of Directive 1999/45/EC
into a recast in order to incorporate the necessary amendments.

5.           The recast proposal was
drawn up on the basis of a preliminary consolidation,
in 22 official languages, of Directive 1999/45/EC and the
instruments amending it, carried out by the Publications Office of the European
Union, by means of a data‑processing system. Where the Articles
have been given new numbers, the correlation between the old and the new
numbers is shown in a table set out in Annex IX to the recast Directive.

ê 1999/45/EC
(adapted)

2012/0007 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the classification, packaging and
labelling of dangerous preparations

(Recast)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article Ö 114 Õ thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[4],

Acting in accordance with the ordinary
legislative procedure[5],

Whereas:

ò new

(1)
Directive 1999/45/EC
of the European Parliament and of the Council of 31 May 1999 concerning
the approximation of the laws, regulations and administrative provisions of the
Member States relating to the classification, packaging and labelling of
dangerous preparations[6]
has been substantially amended several times[7].
Since further amendments are to be made, it should be recast in the interests
of clarity.

(2)
The approximation of
the rules existing in the Member States relating to classification, packaging
and labelling of certain dangerous preparations is essential for setting equal
competition conditions and the functioning of the internal market.

ê 1999/45/EC
recital 3 (adapted)

(3)
Measures for the approximation of the provisions
of the Member States affecting the functioning of the internal market Ö should Õ, in so far as
they concern health, safety and protection of man and the environment, adopt a
high level of protection as a basis. This Directive Ö should Õ, at the same
time, ensure protection for the general public, and, in particular, persons who
come into contact with dangerous preparations in the course of their work or in
the pursuit of a hobby, protection for consumers and for the environment.

ê 1999/45/EC
recital 8 (adapted)

(4)
The number of animals used for experiments
should be reduced to a minimum, in accordance with the provisions of Ö Directive 2010/63/EU of the European Parliament and of the Council of
22 September 2010 on the protection of animals used for scientific
purposes Õ[8]. Ö Pursuant
to Article 4(1) of that Directive Member States are to
ensure that, wherever possible, a scientifically satisfactory method or testing
strategy, not entailing the use of live animals, are used instead of a
procedure within the meaning of that Directive, defined as any use, invasive or
non-invasive, of an animal for experimental or other scientific purposes, with
known or unknown outcome, or educational purposes, which may cause the animal a
level of pain, suffering, distress or lasting harm equivalent to, or higher
than, that caused by the introduction of a needle in accordance with good
veterinary practice. Õ Therefore, this Directive makes use of the results of assessments of
toxicological and ecotoxicological properties only when these are already known
and entails no obligation to conduct further experiments on animals.

ê 1999/45/EC
recital 14 (adapted)

(5)
Although munitions are not covered by this
Directive, explosives marketed to produce an explosive or pyrotechnic effect
may, through their chemical composition, present dangers to health. It is
therefore necessary as part of a transparent information process to classify
them Ö in
accordance with this Directive Õ and assign to
them a safety data sheet in accordance with Ö Regulation
(EC) No 1907/2006 of the European Parliament and of the Council of
18 December 2006 concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH), establishing a European Chemicals Agency,
amending Directive 1999/45/EC and repealing Council Regulation (EEC)
No 793/93 and Commission Regulation (EC) No 1488/94 as well as
Council Directive 76/769/EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC[9], Õ and also to
label them in accordance with the international rules used for the transport of
dangerous goods.

ê 1999/45/EC
recital 12 (adapted)

(6)
Ö Regulation (EC) No 1107/2009 of the European Parliament and of the
Council of 21 October 2009 concerning the placing of plant protection
products on the market and repealing Council Directives 79/117/EEC and
91/414/EEC Õ[10] and Directive 98/8/EC of
the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market[11],
in contrast to the provisions applicable to chemical preparations covered by
this Directive, provide for an authorisation procedure for each product on the
basis of a dossier presented by the applicant and an assessment carried out by
the competent authority in each Member State. Furthermore, that authorisation
procedure includes a control relating specifically to the classification,
packaging and labelling of each product before it is placed on the market. It
is appropriate, as part of a clear and transparent information process, to
classify and label plant protection products Ö and
biocidal products Õ according to
the provisions of this Directive, and also to provide instructions for use in
accordance with the results of the evaluation carried out in the framework of Ö Regulation
(EC) No 1107/2009 and Directive 98/8/EC Õ and to ensure
that the labelling satisfies the high level of protection sought by both this
Directive and Ö Regulation (EC)
No 1107/2009 or Directive 98/8/EC respectively Õ. In addition,
a safety data sheet has to be established for plant protection products Ö and
biocidal products Õ in accordance
with Ö Regulation
(EC) No 1907/2006 Õ.

ê 1999/45/EC
recital 5 (adapted)

(7)
It is necessary to provide Ö for Õ concentration
limits expressed as a volume/volume percentage in the case of preparations
marketed in gaseous form.

ê 1999/45/EC
recital 9

(8)
It is necessary to define what human experience
might be considered for the evaluation of the health hazards of a preparation.
If clinical studies may be accepted, it is taken as given that such studies
comply with the Helsinki Declaration and the Guidelines for Good Clinical
Practice of the Organisation for Economic Co-operation and Development.

ê Corrigendum
1907/2006 recital 57 (OJ L 136, 29.5.2007, p. 3)
(adapted)

(9)
As the existing safety data sheet is already
being used as a communication tool within the supply chain of substances and
preparations, Ö has been
developed Õ further and Ö has been
made Õ an integral
part of the system established by Regulation Ö (EC)
No 1907/2006, it should be removed from this Directive Õ.

ê Corrigendum
2006/121/EC recital 1 (OJ L 136, 29.5.2007, p. 281)
(adapted)

(10)
Ö Due
to Õ the adoption
of Regulation (EC) No 1907/2006, Council Directive 67/548/EEC of
27 June 1967 on the approximation of the laws, regulations and
administrative provisions relating to the classification, packaging and
labelling of dangerous substances[12]
Ö has been Õ adapted and
its rules on the notification and risk assessment of chemicals Ö have been Õ deleted. Ö This
Directive should be adapted accordingly. Õ

ê 440/2008
recital 2 (adapted)

(11)
Annex V to Directive 67/548/EEC, Ö setting
out methods for the determination of the physico-chemical properties, toxicity
and ecotoxicity of substances and preparations, Õ has been
deleted by Directive 2006/121/EC of the European Parliament and of the
Council[13]
with effect from 1 June 2008. Ö The
references to that Annex in this Directive should be adapted accordingly. Õ

ê 1272/2008
recital 53 (adapted)

(12)
In order to take full account of the work and
experience accumulated under Directive 67/548/EEC, including the
classification and labelling of specific substances listed in Annex I Ö to
that Õ Directive, all
existing harmonised classifications should be converted into new harmonised
classifications using the new criteria. Moreover, as the applicability of
Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006[14] is deferred and the harmonised classifications in accordance with
the criteria of Directive 67/548/EEC are relevant for the classification of
substances and mixtures during the ensuing transition period, all existing
harmonised classifications should also be placed unchanged in an annex to Ö that Õ Regulation. By
subjecting all future harmonisations of classifications to Ö that Õ Regulation,
inconsistencies in harmonised classifications of the same substance under the
existing and the new criteria should be avoided.

ê 2006/8/EC
recital 1 (adapted)

(13)
Preparations composed of
more than one substance being classified in Ö Table 3.2
of Part 3 of Annex VI to Regulation (EC)
No 1272/2008 Õ as
carcinogenic, mutagenic and/or toxic for reproduction Ö had to Õ be labelled
with risk phrases (R phrases) to indicate both category 1 or 2 and
category 3 classification. However, providing both R phrases sends a
conflicting message. Preparations should therefore only be classified and labelled with the higher category.

ê 2001/60/EC
recital 2 (adapted)

(14)
Ö The references
to R phrase R40 in Directive 67/548/EEC were amended by Õ Commission
Directive 2001/59/EC[15]
when Ö R phrase R40 was Õ assigned to
carcinogens of category 3. Consequently, the old wording of R phrase R40 Ö became Õ R68 and Ö was used Õ for mutagens
of category 3 and for certain substances with non-lethal irreversible effects. Ö The references to R phrase R40 in this Directive should be adapted
accordingly. Õ

ê 2001/60/EC
recital 3 (adapted)

(15)
Annex VI to Directive 67/548/EEC Ö as amended by Directive 2001/59/EC gives Õ clear advice
on the classification of substances and preparations for corrosive effects. Ö In this
Directive, preparations should therefore be classified Õ accordingly.

ê 2001/60/EC
recital 4 (adapted)

(16)
It is known that cement preparations containing chromium (VI) may cause allergic
reactions in certain circumstances. Such preparations Ö should Õ display Ö the relevant Õ warning label.

ê 2001/60/EC
recital 1 (adapted)

(17)
Ö Directive 67/548/EEC as amended by Õ Commission
Directive 98/98/EC[16]
provides for new criteria and a new R phrase (R67) for vapours which may
cause drowsiness and dizziness. Ö Preparations should be classified and labelled accordingly Õ.

ê 1999/45/EC
recital 7 (adapted)

(18)
Criteria developed for classifying and labelling
substances dangerous for the environment were introduced Ö together with the appropriate symbols, indications of danger, risk
phrases and safety advice required to appear on labelling, Õ by Ö Council Directive 92/32/EEC of 30 April 1992 amending for
the seventh time Directive 67/548/EEC on the approximation of the laws,
regulation and administrative provisions relating to the classification,
packaging and labelling of dangerous substances[17] and by Commission Directive
93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time
Council Directive 67/548/EEC on the approximation of the laws, regulation and
administrative provisions relating to the classification, packaging and
labelling of dangerous substances[18]. Õ Provisions Ö are required Õ at Ö Union Õ level on the
classification and labelling of preparations to take account of their effects
on the environment, and it is therefore necessary to Ö provide for Õ a method for
assessing the hazards of a given preparation for the environment either by a
calculation method, or by determining the ecotoxicological properties by test
methods under certain conditions.

ê 2006/8/EC
recital 2 (adapted)

(19)
For substances very
toxic to the aquatic environment (classified as N) and assigned the R phrases
R50 or R50/53, specific concentration limits (SCLs) are applied to substances
listed in Table 3.2 of Part 3 of Annex VI to Regulation (EC)
No 1272/2008 in order to avoid an underestimation of the hazard. This measure
creates distortions between preparations containing substances listed in Ö that Õ Annex, to which SCLs are applied, and those
preparations containing substances not yet included in Ö that Õ Annex, but classified and labelled provisionally in
accordance with Article 6 of Directive 67/548/EEC and to which no SCLs are
applicable. It is therefore necessary to ensure that SCLs are applied in the
same way to all preparations containing substances very toxic to the aquatic
environment.

ê 2006/8/EC
recital 3 (adapted)

(20)
Directive 2001/59/EC revised the criteria in
Annex VI to Directive 67/548/EEC for the classification and labelling of
ozone depleting substances. The revised Annex III now only provides for the
assignment of the symbol N in addition to R phrase R59. Ö Preparations should be classified and labeled accordingly. Õ

ê 1999/45/EC
recital 20

(21)
The confidentiality of certain substances
contained in the preparations should be guaranteed, and it is therefore
necessary to institute a system which allows the person responsible for placing
the preparation on the market to request confidentiality for such substances.

ê 1999/45/EC
recital 16 (adapted)

(22)
The label constitutes a basic tool for users of
the dangerous preparations in so far as it provides them with the initial
essential concise information. It nevertheless needs to be supplemented by a
two-fold system of more detailed information, consisting firstly of the safety
data sheet intended for professional users Ö as provided for in Regulation (EC) No 1907/2006 Õ and secondly
of the bodies appointed by the Member States which are responsible for the
provision of information solely for medical purposes, both preventive and
curative.

ê 1999/45/EC
recital 4

(23)
Containers containing certain categories of
dangerous preparations offered or sold to the general public must be fitted
with child-resistant fastenings and/or carry a tactile warning of danger.
Certain preparations not falling within these categories of danger may
nevertheless, owing to their composition, present a danger for children. The
packaging of such preparations should therefore be equipped with
child-resistant fastenings.

ê 1999/45/EC
recital 15 (adapted)

(24)
In order to take account
of certain preparations which, although they are not considered dangerous under
this Directive, may nevertheless present a danger for users, it is necessary Ö that Õ certain
provisions of this Directive cover such preparations.

ê 1999/45/EC
recital 6 (adapted)

(25)
This Directive contains special labelling
provisions applicable to certain preparations. To ensure an adequate level of
protection for man and the environment, special labelling provisions Ö should Õ also be Ö laid
down Õ for certain
preparations which, although not dangerous within the meaning of this
Directive, may nevertheless present a danger to the user.

ê 1999/45/EC
recital 19 (adapted)

(26)
In the case of preparations classified as
dangerous within the meaning of this Directive, it is appropriate to permit
Member States to allow certain derogations with respect to labelling where the
packaging is too small, or otherwise unsuitable for labelling, or where such
small packaging or such small quantities are involved that there is no reason
to fear any danger to man or the environment. In such cases appropriate
consideration should also be given to the approximation of the relevant provisions
at Ö Union Õ level.

ê 1999/45/EC
recital 13

(27)
It is appropriate to provide, in relation to
environmental labelling, that specific exemptions or specific provisions may be
decided upon in specific cases where it can be demonstrated that the overall
environmental impact of the product types in question is lower than that of
corresponding product types.

ò new

(28)
In order to supplement
or amend certain non-essential elements of this Directive, the power to adopt
acts in accordance with Article 290 of the Treaty on the Functioning of the
European Union should be delegated to the Commission in respect of determining
exemptions to certain provisions on environmental labelling, deciding on measures
in the framework of the special provisions on the labelling of certain
preparations and adapting the Annexes to technical progress. It is of
particular importance that the Commission carry out appropriate consultations
during its preparatory work, including at expert level.       
The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and Council.

(29)
In order to ensure
uniform conditions for the implementation of this Directive, implementing
powers should be conferred on the Commission. Those powers should be exercised
in accordance with Regulation (EU) No 182/2011 of the European Parliament and
of the Council of 16 February 2011 laying down the rules and general principles
concerning mechanisms for control by Member States of the Commission’s exercise
of implementing powers[19].

(30)
This Directive should
be without prejudice to the obligations of the Member States relating to the
time-limits for transposition into national law of the Directives set out in
Annex VIII, Part B,

ê 1999/45/EC

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Objectives
and scope

1. This Directive aims at the approximation
of the laws, regulations and administrative provisions of the Member States
relating to the classification, packaging and labelling of dangerous
preparations, and to the approximation of specific provisions for certain
preparations which may present hazards, whether or not they are classified as
dangerous within the meaning of this Directive, when such preparations are
placed on the market of the Member States.

2. This
Directive shall apply to preparations which:

ê 1999/45/EC
(adapted)

(a)          contain at least one dangerous
substance within the meaning of Article 2; Ö and Õ

ê 1999/45/EC

(b)          are considered dangerous within
the meaning of Article 5, 6 or 7.

ê 1999/45/EC
(adapted)

3. The specific provisions set out in
Article 9 and Annex IV, Ö and those
set out Õ in
Article 10 and Annex V shall also apply to preparations which are not
considered dangerous within the meaning of Article 5, 6 or 7 but which may
nevertheless present a specific hazard.

4. Without prejudice to Ö Regulation
(EC) No 1107/2009 Õ, the articles on classification, packaging Ö and Õ labelling of
this Directive shall apply to plant protection products.

ê 1999/45/EC

5. This
Directive shall not apply to the following preparations in the finished state,
intended for the final user:

(a)          veterinary medicinal products and
medicinal products for human use, as defined in Directives 2001/82/EC[20] and 2001/83/EC[21] of the European Parliament and
of the Council respectively;

(b)          cosmetic products as defined in Council
Directive 76/768/EEC[22];

(c)          mixtures of substances which, in
the form of waste, are covered by Directive 2008/98/EC of the European Parliament and of the Council[23];

(d)          foodstuffs;

(e)          animal feedingstuffs;

(f)           preparations containing
radioactive substances as defined by Council Directive 96/29/Euratom[24];

ê 1999/45/EC
(adapted)

(g)          medical devices which are
invasive or used in direct physical contact with the human body in so far as Ö Union Õ measures lay
down provisions for the classification and labelling of dangerous substances
and preparations which ensure the same level of information provision and
protection as this Directive.

ê 1999/45/EC

6. This
Directive shall not apply to:

(a)          the carriage of dangerous
preparations by rail, road, inland waterway, sea or air;

(b)          preparations in transit which are
under customs supervision, provided they do not undergo any treatment or
processing.

Article 2

Definitions

ê 1999/45/EC (adapted)

1. For the
purposes of this Directive Ö , the
following definitions shall apply Õ:

ê 1999/45/EC

(a)          ‘substances’ means chemical
elements and their compounds in the natural state or obtained by any production
process, including any additive necessary to preserve the stability of the
products and any impurity deriving from the process used, but excluding any
solvent which may be separated without affecting the stability of the substance
or changing its composition;

(b)          ‘preparations’ means mixtures or
solutions composed of two or more substances;

(c)          ‘polymer’ means a substance
consisting of molecules characterised by the sequence of one or more types of
monomer units and comprising a simple weight majority of molecules containing
at least three monomer units which are covalently bound to at least one other
monomer unit or other reactant and consists of less than a simple weight
majority of molecules of the same molecular weight. Such molecules must be
distributed over a range of molecular weights wherein differences in the
molecular weight are primarily attributable to differences in the number of
monomer units. In the context of this definition a ‘monomer unit’ means the
reacted form of a monomer in a polymer;

ê 1999/45/EC
(adapted)

(d)          ‘placing on the market’ means
making available to third parties. Importation into the customs territory Ö of the Union Õ shall be
deemed to be placing on the market for the purposes of this Directive;

ê 1999/45/EC

(e)          ‘scientific research and
development’ means scientific experimentation, analysis or chemical research
carried out under controlled conditions; it includes the determination of
intrinsic properties, performance and efficacy as well as scientific
investigation related to product development;

(f)           ‘process-orientated research and
development’ means the further development of a substance in the course of
which pilot plant or production trials are used to test the fields of
application of the substance;

ê 1999/45/EC
(adapted)

(g)          ‘Einecs’ means the European
Inventory of Existing Commercial Chemical Substances. This inventory contains
the definitive list of all chemical substances deemed to be on the Ö Union Õ market on
18 September 1981.

ê 1999/45/EC

2. The
following are ‘dangerous’ within the meaning of this Directive:

(a)          explosive substances and
preparations: solid, liquid, pasty or gelatinous substances and preparations
which may also react exothermically without atmospheric oxygen thereby quickly
evolving gases, and which, under defined test conditions, detonate, quickly
deflagrate or upon heating explode when partially confined;

(b)          oxidising substances and
preparations: substances and preparations which give rise to a highly
exothermic reaction in contact with other substances, particularly flammable
substances;

(c)          extremely flammable substances
and preparations: liquid substances and preparations having an extremely low
flash-point and a low boiling-point and gaseous substances and preparations
which are flammable in contact with air at ambient temperature and pressure;

(d)          highly flammable substances and
preparations:

(i)      substances and preparations which may
become hot and finally catch fire in contact with air at ambient temperature
without any application of energy; or

(ii)     solid substances and preparations
which may readily catch fire after brief contact with a source of ignition and
which continue to burn or to be consumed after removal of the source of
ignition; or

(iii)     liquid substances and preparations
having a very low flash-point; or

(iv)    substances and preparations which, in
contact with water or damp air, evolve extremely flammable gases in dangerous
quantities;

(e)          flammable substances and
preparations: liquid substances and preparations having a low flash-point;

(f)           very toxic substances and
preparations: substances and preparations which in very low quantities cause
death or acute or chronic damage to health when inhaled, swallowed or absorbed
via the skin;

(g)          toxic substances and preparations:
substances and preparations which in low quantities cause death or acute or
chronic damage to health when inhaled, swallowed or absorbed via the skin;

(h)          harmful substances and
preparations: substances and preparations which may cause death or acute or
chronic damage to health when inhaled, swallowed or absorbed via the skin;

(i)           corrosive substances and
preparations: substances and preparations which may, on contact with living
tissues, destroy them;

(j)           irritant substances and
preparations: non-corrosive substances and preparations which, through
immediate, prolonged or repeated contact with the skin or mucous membrane, may
cause inflammation;

(k)          sensitising substances and
preparations: substances and preparations which, if they are inhaled or if they
penetrate the skin, are capable of eliciting a reaction of hypersensitisation
such that on further exposure to the substance or preparation, characteristic
adverse effects are produced;

(l)           carcinogenic substances and
preparations: substances or preparations which, if they are inhaled or ingested
or if they penetrate the skin, may induce cancer or increase its incidence;

(m)         mutagenic substances and
preparations: substances and preparations which, if they are inhaled or
ingested or if they penetrate the skin, may induce heritable genetic defects or
increase their incidence;

(n)          substances and preparations which
are toxic for reproduction: substances and preparations which, if they are
inhaled or ingested or if they penetrate the skin, may produce, or increase the
incidence of, non-heritable adverse effects in the progeny and/or an impairment
of male or female reproductive functions or capacity;

(o)          substances and preparations which
are dangerous for the environment: substances and preparations which, were they
to enter the environment, would or could present an immediate or delayed danger
for one or more components of the environment.

Article 3

Determination
of dangerous properties of preparations

1. The
evaluation of the hazards of a preparation shall be based on the determination
of:

(a)          physico-chemical properties;

(b)          properties affecting health;

(c)          environmental properties.

ê 1999/45/EC (adapted)

Those different properties shall be
determined in accordance with Articles 5, 6 and 7.

ê 1999/45/EC

Where laboratory tests are conducted, they
shall be carried out on the preparation as placed on the market.

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 1 (adapted)

2. Where the
determination of dangerous properties is carried out in accordance with
Articles 5, 6 and 7, all dangerous substances within the meaning of
Article 2 and in particular Ö the
following shall be taken into consideration in accordance with the provisions
laid down in the method used Õ:

(a)          Ö substances Õ listed in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç;

(b)          Ö substances Õ classified and
labelled provisionally by the person responsible for the placing on the market
in accordance with Article 6 of Directive 67/548/EEC.

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(a)

3. For preparations covered by this
Directive, dangerous substances as referred to in paragraph 2 which are
classified as dangerous on the basis of their health and/or environmental
effects, whether they are present as impurities or additives, shall be taken
into consideration when their concentrations are equal to, or greater than,
those defined in the following table unless lower values are given in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç, or in
Part B of Annex II to this Directive or in Part B of
Annex III thereto, unless otherwise specified in Annex V to this
Directive.

Category of danger of the substance || Concentration to take into consideration for

gaseous preparations % vol/vol || other preparations % w/w

Very toxic || ≥ 0,02 || ≥ 0,1

Toxic || ≥ 0,02 || ≥ 0,1

Carcinogenic Category 1 or 2 || ≥ 0,02 || ≥ 0,1

Mutagenic Category 1 or 2 || ≥ 0,02 || ≥ 0,1

Toxic for reproduction Category 1 or 2 || ≥ 0,02 || ≥ 0,1

Harmful || ≥ 0,2 || ≥ 1

Corrosive || ≥ 0,02 || ≥ 1

Irritant || ≥ 0,2 || ≥ 1

Sensitising || ≥ 0,2 || ≥ 1

Carcinogenic Category 3 || ≥ 0,2 || ≥ 1

Mutagenic Category 3 || ≥ 0,2 || ≥ 1

Toxic for reproduction Category 3 || ≥ 0,2 || ≥ 1

Dangerous for the environment N || || ≥ 0,1

Dangerous for the environment ozone || ≥ 0,1 || ≥ 0,1

Dangerous for the environment || || ≥ 1

Article 4

General
principles of classification and labelling

1. The classification of dangerous
preparations according to the degree and specific nature of the hazards
involved shall be based on the definitions of categories of danger laid down in
Article 2.

2. The general principles of the
classification and labelling of preparations shall be applied in accordance
with the criteria laid down in Annex VI to Directive 67/548/EEC, save
where alternative criteria referred to in Article 5, 6, 7 or 10 and the
relevant Annexes of this Directive are applied.

Article 5

Evaluation
of the hazards deriving from physico-chemical properties

ê 1999/45/EC
(adapted)

1. The hazards of a preparation deriving
from its physico-chemical properties shall be assessed by determining, by means
of the methods specified in Part A of the Annex to Council Regulation (EC)
No 440/2008[25],
the physico-chemical properties of the preparation necessary for appropriate
classification and labelling in accordance with the criteria laid down in
Annex VI to Directive Ö 67/548/EEC Õ.

ê 1999/45/EC

2. By way of
derogation from paragraph 1, the determination of the explosive,
oxidising, extremely flammable, highly flammable, or flammable properties is
not necessary provided that:

(a)          none of the constituents
possesses such properties and that, on the basis of the information available
to the manufacturer, the preparation is unlikely to present hazards of this
kind;

(b)          in the event of a change in the
composition of a preparation of known composition, scientific evidence indicates
that a reassessment of the hazards will not lead to a change in classification;

(c)          preparations placed on the market
in the form of aerosols satisfy the provisions of Article 8(1a) of Council
Directive 75/324/EEC[26].

3. For certain cases for which the methods
laid down in Part A of the Annex to Regulation (EC) No 440/2008
are not appropriate, alternative calculation methods are laid down in
Part B of Annex I to this Directive.

4. Certain exemptions from the application
of the methods laid down in Part A of the Annex to Regulation (EC)
No 440/2008 are referred to in Part A of Annex I to this
Directive.

ê 1999/45/EC
(adapted)

5. The hazards deriving from the
physico-chemical properties of a preparation covered by Ö Regulation
(EC) No 1107/2009 Õ shall be
assessed by determining the physico-chemical properties of the preparation
necessary for appropriate classification in accordance with the criteria set
out in Annex VI to Directive 67/548/EEC. Those properties shall be
determined by means of the methods laid down in Part A of the Annex to
Regulation (EC) No 440/2008 unless other internationally recognised
methods are acceptable in accordance with the provisions of Ö Commission
Regulations (EU) No 544/2011[27]
and (EU) No 545/2011[28] Õ.

Article 6

Evaluation
of health hazards

1. The
health hazards of a preparation shall be assessed by one or more of the
following procedures:

(a)          by a conventional method
described in Annex II;

(b)          by determining the toxicological
properties of the preparation necessary for appropriate classification in
accordance with the criteria in Annex VI to Directive 67/548/EEC.
Those properties shall be determined by means of the methods laid down in
Part B of the Annex to Regulation (EC) No 440/2008, unless, in the
case of plant protection products, other internationally recognised methods are
acceptable in accordance with the provisions of Ö Regulations
(EU) No 544/2011 and (EU) No 545/2011 Õ.

2. Without prejudice to the requirements of
Ö Regulation (EC)
No 1107/2009 Õ, only where it
can be scientifically demonstrated by the person responsible for placing the
preparation on the market that the toxicological properties of the preparation
cannot correctly be determined by the method outlined in point (a) of
paragraph 1, or on the basis of existing test results on animals, the
methods outlined in point (b) of paragraph 1 may be used, provided
they are justified or specifically authorised under Article 12 of
Directive 86/609/EEC.

When a toxicological property is
established by the methods outlined in point (b) of paragraph 1 to
obtain new data, the test shall be conducted in compliance with the principles
of good laboratory practice provided for in Directive 2004/10/EC of the
European Parliament and the Council[29]
and the provisions of Directive 86/609/EEC, in particular Articles 7
and 12 thereof.

Subject to the provisions of
paragraph 3, where a toxicological property has been established on the
basis of both the methods outlined in points (a) and (b) of
paragraph 1, the results from the methods outlined in point (b) of
paragraph 1 shall be used for classifying the preparation, except in the
case of carcinogenic, mutagenic or toxic effects for reproduction for which
only the method outlined in point (a) of paragraph 1 shall be used.

Any of the toxicological properties of the
preparation which are not assessed by the method outlined in point (b) of
paragraph 1 shall be assessed in accordance with the method outlined in point (a)
of paragraph 1.

3.
Furthermore, where it can be demonstrated by epidemiological studies, by
scientifically valid case studies as specified by Annex VI to
Directive 67/548/EEC or by statistically backed experience, such as the
assessment of data from poison information units or concerning occupational
diseases:

–
that toxicological effects on man differ from
those suggested by the application of the methods outlined in paragraph 1,
then the preparation shall be classified according to its effects on man,

–
that, owing to effects such as potentiation, a
conventional assessment would underestimate the toxicological hazard, those
effects shall be taken into account in classifying the preparation,

–
that, owing to effects such as antagonism, a
conventional assessment would overestimate the toxicological hazard, those
effects shall be taken into account in classifying the preparation.

4. For
preparations of a known composition, with the exception of those covered by Ö Regulation
(EC) No 1107/2009 Õ, classified in
accordance with point (b) of paragraph 1, a new evaluation of health
hazard by the methods outlined in either point (a) or point (b) of
paragraph 1 shall be performed whenever:

–
changes of composition of the initial
concentration, as a weight/weight or volume/volume percentage, of one or more
of the dangerous constituents are introduced by the manufacturer, in accordance
with the following table:

Initial concentration range of the constituent || Permitted variation in initial concentration of the constituent

≤ 2,5 % || ± 30 %

> 2,5 ≤ 10 % || ± 20 %

> 10 ≤ 25 % || ± 10 %

> 25 ≤ 100 % || ± 5 %

–
changes of composition involving the
substitution or addition of one or more constituents, which may or may not be
dangerous within the meaning of the definitions set out in Article 2, are
introduced by the manufacturer.

This new evaluation will apply unless there
is valid scientific justification for considering that a re-evaluation of the
hazard will not result in a change of classification.

Article 7

Evaluation
of environmental hazards

1. The
hazards of a preparation for the environment shall be assessed by one or more
of the following procedures:

(a)          by a conventional method
described in Annex III ;

(b)          by determining the hazardous
properties of the preparation for the environment necessary for appropriate
classification in accordance with the criteria set out in Annex VI to
Directive 67/548/EEC. Those properties shall be determined by means of the
methods laid down in Part C of the Annex to Regulation (EC)
No 440/2008 unless, in the case of plant protection products, other
internationally recognised methods are acceptable in accordance with the
provisions of Ö Regulations (EU)
No 544/2011 and (EU) No 545/2011 Õ. Without
prejudice to the testing requirements Ö laid down
in or pursuant to Regulation (EC) No 1107/2009 Õ, the
conditions for application of the test methods are described in Part C of
Annex III to this Directive.

2. Where an ecotoxicological property is
established by one of the methods outlined in point (b) of paragraph 1
to obtain new data, the test shall be conducted in compliance with the
principles of good laboratory practice provided for in Directive 2004/10/EC and
with the provisions of Directive 86/609/EEC.

Where the environmental hazards have been
assessed in compliance with both of the procedures mentioned above, the results
of the methods referred to in point (b) of paragraph 1 shall be used
for classifying the preparation.

3. For preparations of a known composition,
with the exception of those covered by Ö Regulation
(EC) No 1107/2009 Õ, classified in
accordance with the method outlined in point (b) of paragraph 1, a
new evaluation of environmental hazard either by the method outlined in
point (a) of paragraph 1 or that outlined in point (b) of
paragraph 1 shall be performed whenever:

–
changes of composition of the initial
concentration, as a weight/weight or volume/volume percentage, of one or more
of the dangerous constituents are introduced by the manufacturer, in accordance
with the following table:

Initial concentration range of the constituent || Permitted variation in initial concentration of the constituent

≤ 2,5 % || ± 30 %

> 2,5 ≤ 10 % || ± 20 %

> 10 ≤ 25 % || ± 10 %

> 25 ≤ 100 % || ± 5 %

–
changes of composition involving the
substitution or addition of one or more constituents, which may or may not be
dangerous within the meaning of the definitions set out in Article 2, are
introduced by the manufacturer.

This new evaluation will apply unless there
is valid scientific justification for considering that a re-evaluation of the
hazard will not result in a change of classification.

ê 1999/45/EC

Article 8

Obligations
and duties of the Member States

1. Member States shall take all necessary
measures to ensure that the preparations covered by this Directive cannot be
placed on the market unless they comply with it.

2. In order to ensure compliance with this Directive,
the authorities of the Member States may request information on the composition
of the preparation and any other pertinent information from any person
responsible for placing the preparation on the market.

3. Member
States shall take all necessary measures to ensure that those responsible for
placing the preparation on the market keep at the disposal of the authorities
of the Member States:

(a)          the data used for the
classification and labelling of the preparation;

(b)          any pertinent information relating
to packaging requirements in accordance with point (c) of Article 9,
including the test certificate issued in accordance with Part A of
Annex IX to Directive 67/548/EEC;

(c)          the data used for establishing
the safety data sheet, in accordance with Article 31 of Regulation (EC)
No 1907/2006.

4. Member States and the Commission shall
exchange information concerning the name and full address of the national
authority or authorities responsible for communicating and exchanging
information relating to the practical application of this Directive.

Article 9

Packaging

1. Member
States shall take all necessary measures to ensure that:

(a)          preparations within the meaning of
Article 1(2) and preparations covered by Annex IV pursuant to
Article 1(3) cannot be placed on the market unless their packaging
satisfies the following requirements:

(i)      it shall be so designed and
constructed that its contents cannot escape; this requirement shall not apply
where special safety devices are prescribed;

(ii)     the materials constituting the
packaging and fastenings must not be susceptible to adverse attack by the
contents, or liable to form dangerous compounds with the contents;

(iii)     packaging and fastenings must be
strong and solid throughout to ensure that they will not loosen and will safely
meet the normal stresses and strains of handling;

(iv)    containers fitted with replaceable
fastening devices shall be so designed that the packaging can be refastened
repeatedly without the contents escaping;

(b)          containers which contain preparations
within the meaning of Article 1(2) and preparations covered by
Annex IV pursuant to Article 1(3) offered or sold to the general
public do not have:

(i)      either a shape and/or graphic
decoration likely to attract or arouse the active curiosity of children or to
mislead consumers; or

(ii)     a presentation and/or a designation
used for foodstuffs or animal feedingstuffs or medicinal or cosmetic products;

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(b)

(c)          containers which contain certain
preparations offered or sold to the general public covered by Annex IV :

(i)      are fitted with child-resistant
fastenings; Ö and/or Õ

(ii)     carry a tactile warning of danger.

The devices must conform to the technical
specifications given in Parts A and B of Annex IX to
Directive 67/548/EEC.

2. The packaging of preparations shall be
deemed to satisfy the requirements of points (a)(i), (ii) and (iii) of
paragraph 1 if it complies with the requirements for carriage of dangerous
goods by rail, road, inland waterway, sea or air.

Article 10

Labelling

1. Member
States shall take all necessary measures to ensure that:

(a)          preparations within the meaning
of Article 1(2) cannot be placed on the market unless the labelling on
their packaging satisfies all the requirements of this Article and the specific
provisions of Parts A and B of Annex V;

(b)          preparations within the meaning
of Article 1(3) as defined in Parts B and C of Annex V cannot be
placed on the market unless the labelling on their packaging satisfies the
requirements of points (a) and (b) of paragraph 3 of this Article and the
specific provisions of Parts B and C of Annex V.

2. With
respect to plant protection products subject to Ö Regulation
(EC) No 1107/2009 Õ, the labelling
requirements in accordance with this Directive shall be accompanied by the
following wording:

‘To avoid risks to man and the environment,
comply with the instructions for use.’

This labelling shall be without prejudice
to the information required in accordance with Article Ö 65 Õ of Ö Regulation
(EC) No 1107/2009 Õ and Ö Annexes I
and III Õ to Ö Commission
Regulation (EU) No 547/2011[30] Õ.

3. The
following information shall be clearly and indelibly marked on any package:

(a)          the trade name or designation of
the preparation;

(b)          the name, full address and
telephone number of the person established in the Ö Union Õ who is
responsible for placing the preparation on the market, whether it be the
manufacturer, the importer or the distributor;

(c)          the chemical name of the substance or
substances present in the preparation in accordance with the following detailed
rules:

(i)      for preparations classified T+,
T, Xn in accordance with Article 6, only the substances T+,
T, Xn present in concentrations equal to, or greater than, the
lowest limit (limit Xn) for each of them laid down in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or, failing
that, Part B of Annex II to this Directive have to be taken into
consideration;

(ii)     for preparations classified C in
accordance with Article 6, only C substances present in concentrations
equal to, or greater than, the lowest limit (limit Xi) laid down in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or, failing
that, Part B of Annex II to this Directive have to be taken into
consideration;

(iii)     the name of the substances which have given rise to the
classification of the preparation in one or more of the following danger
categories Ö shall be
mentioned on the label Õ:

–
carcinogen category 1, 2 or 3,

–
mutagen category 1, 2 or 3,

–
toxic for reproduction category 1, 2 or 3,

–
very toxic, toxic or harmful due to non-lethal
effects after a single exposure,

–
toxic or harmful due to severe effects after
repeated or prolonged exposure,

–
sensitising.

The chemical name shall be one of the
designations listed in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or an
internationally recognised chemical nomenclature if no corresponding
designation is yet listed in that Annex;

(iv)     the name of any substance which led to the classification
of the preparation in the following danger categories Ö need not
be mentioned on the label, unless the substance has to be mentioned pursuant to
points (i), (ii) or (iii) Õ:

–
explosive,

–
oxidising,

–
extremely flammable,

–
highly flammable,

–
flammable,

–
irritant,

–
dangerous for the environment;

(v)     as a general rule, a maximum of four
chemical names shall suffice to identify the substances primarily responsible
for the major health hazards which have given rise to the classification and
the choice of the corresponding phrases referring to the risk involved. In some
cases, more than four chemical names may be necessary;

(d)          Ö the
danger symbol(s) and indication(s) of danger. Õ The danger
symbols, where specified in this Directive, and indications of the dangers
involved in the use of the preparation, shall be in accordance with
Annexes II and VI to Directive 67/548/EEC and shall be applied in
accordance with the evaluation of the hazards carried out in accordance with
Annexes I, II and III to this Directive.

Where more than one danger symbol must be assigned to a preparation
the obligation to apply the symbol:

(i)      T shall make the symbols C and X
optional unless otherwise specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç;

(ii)     C shall make the symbol X
optional;

(iii)     E shall make the symbols F and
O optional;

(iv)    Xn shall make the
symbol Xi optional.

The symbol(s) shall be printed in black on an
orange-yellow background;

(e)          Ö the risk
phrases (R phrases). Õ The
indications concerning special risks (R phrases) shall comply with
Annexes III and VI to Directive 67/548/EEC and shall be assigned in
accordance with the results of the hazard evaluation carried out in accordance
with Annexes I, II, and III to this Directive.

As a general rule, a maximum of six
R phrases shall suffice to describe the risks; for this purpose, the
combined phrases listed in Annex III to Directive 67/548/EEC shall be
regarded as single phrases. However, if the preparation falls within more than
one danger category, those standard phrases shall cover all the principal
hazards associated with the preparation. In some cases more than six
R phrases may be necessary.

The standard phrases ‘extremely flammable’ or
‘highly flammable’ need not be used where they describe an indication of danger
used in accordance with point (d) of this paragraph;

(f)           Ö the
safety advice (S phrases). Õ The
indications giving safety advice (S phrases) shall comply with
Annex IV and with Annex VI to Directive 67/548/EEC and shall be
assigned in accordance with the results of the hazard evaluation carried out in
accordance with Annexes I, II and III to this Directive.

As a general rule, a maximum of six
S phrases shall suffice to formulate the most appropriate safety advice;
for this purpose the combined phrases listed in Annex IV to
Directive 67/548/EEC shall be regarded as single phrases. However, in some
cases more than six S phrases may be necessary.

Where it is physically impossible to include
the advice on the label or package itself, the package shall be accompanied by
safety advice on the use of the preparation;

(g)          the nominal quantity (nominal
mass or nominal volume) of the contents in the case of preparations offered or
sold to the general public.

ê 1999/45/EC
(adapted)

è1 1137/2008 Art. 1 and Annex, point 3.5.1 (adapted)

ð new

4. è1 In relation to certain preparations classified as
dangerous within the meaning of Article 7, by way of derogation from
points (d), (e) and (f) of paragraph 3 of this Article, the
Commission may ð shall be empowered to adopt delegated
acts in accordance with Article 20 for the purpose of determining ï determine exemptions to
certain provisions on environmental labelling or specific provisions in
relation to environmental labelling, where it can be demonstrated that there
would be a reduction in the environmental impact. Those measures,
designed to amend non-essential elements of this Directive by supplementing it
shall be adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 20a(3). ç Those
exemptions or specific provisions are defined and laid down in Part A or B
of Annex V.

ê 1999/45/EC

5. If the
contents of the package do not exceed 125 ml:

(a)          in the case of preparations that
are classified as highly flammable, oxidising, irritant, with the exception of
those assigned R41, or dangerous for the environment and assigned the
N symbol it shall not be necessary to indicate the R phrases or the
S phrases;

(b)          in the case of preparations that
are classified as flammable or dangerous for the environment and not assigned
the N symbol it shall be necessary to indicate the R phrases but it
shall not be necessary to indicate the S phrases.

ê 1999/45/EC
(adapted)

6. Without prejudice to Ö point 3
of Annex I to Regulation (EU) No 547/2011 Õ, indications
such as ‘non-toxic’, ‘non-harmful’, ‘non‑polluting’, ‘ecological’ or any
other statement indicating that the preparation is not dangerous or likely to
lead to underestimation of the dangers of the preparation in question shall not
appear on the packaging or labelling of any preparation subject to this
Directive.

ê 1999/45/EC

Article 11

Implementation
of the labelling requirements

1. Where the particulars required by
Article 10 appear on a label, that label shall be firmly affixed to one or
more surfaces of the packaging so that those particulars can be read
horizontally when the package is set down normally. The dimensions of the label
are laid down in Annex VI to Directive 67/548/EEC and the label is
intended solely for provision of the information required by this Directive and
if necessary of any supplementary health or safety information.

2. A label shall not be required when the
particulars are clearly shown on the package itself, as specified in
paragraph 1.

3. The colour and presentation of the label
– or, in the case of paragraph 2, of the package – shall be such that the
danger symbol and its background stand out clearly from it.

4. The information required on the label
under Article 10 shall stand out clearly from its background and shall be
of such size and spacing as to be easily read.

Specific provisions regarding the
presentation and format of this information shall be laid down in Annex VI
to Directive 67/548/EEC.

5. Member States may make the placing on
the market of preparations covered by this Directive within their territories
subject to the use of their official language or languages in respect of the
labelling thereof.

6. For the
purposes of this Directive, labelling requirements shall be deemed to be
satisfied:

(a)          in the case of an outer package
containing one or more inner packages, if the outer package is labelled in
accordance with international rules on the transport of dangerous goods and the
inner package or packages are labelled in accordance with this Directive;

(b)          in the case of a single package:

(i)      if such a package is labelled in
accordance with international rules on the transport of dangerous goods and
with points (a), (b), (c), (e) and (f) of Article 10(3); for
preparations classified according to Article 7, the provisions of
Article 10(3)(d) shall additionally apply with respect to the property in
question when it has not been so identified on the label; or

(ii)     where appropriate, for particular
types of packaging such as mobile gas cylinders, if the specific requirements
referred to in Annex VI to Directive 67/548/EEC are complied with.

Where dangerous preparations do not leave the
territory of a Member State, labelling may be permitted which complies with
national rules instead of with international rules on the transport of
dangerous goods.

Article 12

Exemptions
from the labelling and packaging requirements

1. Articles 9, 10 and 11 shall not
apply to explosives placed on the market with a view to obtaining an explosive
or pyrotechnic effect.

2. For certain dangerous preparations
within the meaning of Article 5, 6 or 7 defined in Annex VII which,
in the form in which they are placed on the market, do not present any
physico-chemical risk, or risk to health or to the environment,
Articles 9, 10 and 11 shall not apply.

3. Member
States may also:

(a)          permit the labelling required by
Article 10 to be applied in some other appropriate manner on packages
which are either too small or otherwise unsuitable for labelling in accordance
with Article 11(1) and (2);

(b)          by way of derogation from
Articles 10 and 11 permit the packaging of dangerous preparations which
are classified as harmful, extremely flammable, highly flammable, flammable, irritant
or oxidising to be unlabelled or to be labelled in some other way, if they
contain such small quantities that there is no reason to fear any danger to
persons handling such preparations or to other persons;

(c)          by way of derogation from
Articles 10 and 11, for preparations classified according to
Article 7, permit the packaging of dangerous preparations to be unlabelled
or labelled in some other way if they contain such small quantities that there
is no reason to fear any dangers to the environment;

ê 1999/45/EC
(adapted)

è1 1137/2008 Art. 1 and Annex, point 3.5.2 (adapted)

ð new

(d)          by way of derogation from
Articles 10 and 11 permit the packaging of dangerous preparations which
are not mentioned in points (b) or (c) to be labelled in some other
appropriate way, if the packages are too small for the labelling provided for
in Articles 10 and 11 and there is no reason to fear any danger to persons
handling such preparations or to other persons.

Where this paragraph is applied, the use of
symbols, indications of danger, risk (R) phrases or safety
(S) phrases different to those laid down in this Directive shall not be
permitted.

4. If a Member State makes use of the
options provided for in paragraph 3, it shall forthwith inform the Commission
and Member States thereof. è1 The Commission may decide ð shall be empowered to adopt
delegated acts in accordance with Article 20 for the purpose of amending ï upon measures in the framework of
Annex V ð on the basis of such
information ï. Those measures, designed to amend non-essential
elements of this Directive by supplementing it, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 20a(3). ç

Article 13

Distance
selling

Any advertisement for a preparation within
the meaning of this Directive which enables a member of the general public to
conclude a contract for purchase without first having sight of the label for
that preparation Ö shall Õ make mention
of the type or types of hazard indicated on the label. This requirement is
without prejudice to Directive 97/7/EC of the European Parliament and of
the Council[31].

Article 14

Confidentiality
of chemical names

Where the
person responsible for placing the preparation on the market can demonstrate
that the disclosure on the label or safety data sheet of the chemical identity
of a substance which is exclusively classified as:

–
irritant with the exception of those assigned
R41 or irritant in combination with one or more of the other properties
mentioned in point (c)(iv) of Article 10(3), or

–
harmful or harmful in combination with one or
more of the properties mentioned in point (c)(iv) of Article 10(3)
presenting acute lethal effects alone

will put at risk the confidential nature of
his intellectual property, he may, in accordance with the provisions of
Annex VI, be permitted to refer to that substance either by means of a
name that identifies the most important functional chemical groups or by means
of an alternative name. This procedure may not be applied where the substance
concerned has been assigned a Ö Union Õ exposure
limit.

Where the person responsible for placing a
preparation on the market wishes to take advantage of confidentiality
provisions, he shall make a request to the competent authority of the Member
State in which the preparation is to be first placed on the market.

This request Ö shall Õ be made in
accordance with the provisions of Annex VI and Ö shall Õ provide the
information required in the form in Part A of that Annex. The competent
authority may nevertheless request further information from the person
responsible for placing the preparation on the market if such information
appears necessary in order to evaluate the validity of the request.

The authority of the Member State receiving
a request for confidentiality shall notify the applicant of its decision. The
person responsible for placing the preparation on the market shall forward a
copy of this decision to each of the Member States where he wishes to market
the product.

Confidential information brought to the
attention of the authorities of a Member State or of the Commission shall be Ö kept
secret Õ.

ò new

In all cases such information:

–
may be brought to the
attention only of the competent authority or authorities responsible for receiving
the information necessary for evaluating the foreseeable risks which the
preparations may entail for man and the environment, and examining its
conformity with the requirements of this Directive,

–
may, however, be divulged
to persons directly involved in administrative or legal proceedings involving
sanctions which are undertaken for the purpose of controlling substances placed
on the market and to persons who are to participate or be heard in legislative
proceedings.

ê 1999/45/EC

Article 15

Rights
of Member States regarding safety of workers

This Directive shall not affect the right
of Member States to specify, in compliance with the Treaty, the requirements
they deem necessary to ensure that workers are protected when using the
dangerous preparations in question, provided that this does not mean that the
classification, packaging, and labelling of dangerous preparations are modified
in a way not provided for in this Directive.

Article 16

Bodies
responsible for receiving information relating to health

Member States shall appoint the body or
bodies responsible for receiving information, including chemical composition,
relating to preparations placed on the market and considered dangerous on the
basis of their health effects or on the basis of their physico-chemical
effects.

Member States shall take the necessary
steps to ensure that the appointed bodies provide all the requisite guarantees
for maintaining the confidentiality of the information received. Such
information may only be used to meet any medical demand by formulating
preventive and curative measures, in particular in case of emergency.

Member States shall ensure that the
information is not used for other purposes.

Member States shall ensure that the
appointed bodies have at their disposal all the information required from the
manufacturers or persons responsible for marketing to carry out the tasks for
which they are responsible.

ê 1999/45/EC
(adapted)

Article 17

Free
movement clause

Without prejudice to the provisions set out
in other Ö Union Õ legislation,
Member States may not prohibit, restrict or impede the placing on the market of
preparations because of their classification, packaging Ö and Õ labelling if such
preparations comply with the provisions laid down in this Directive.

ê 1999/45/EC

Article 18

Safeguard
clause

1. Where a Member State has detailed
evidence that a preparation, although satisfying the provisions of this
Directive, constitutes a hazard for man or the environment on grounds relating
to the provisions of this Directive, it may provisionally prohibit the placing
on the market of that preparation or subject it to special conditions in its
territory. It shall immediately inform the Commission and the other Member
States of such action and give reasons for its decision.

2. In the case referred to in
paragraph 1, the Commission shall consult the Member States as soon as
possible.

ê 1137/2008
Art. 1 and Annex, point 3.5.3

ð new

3. The Commission shall ð decide by means of implementing acts. ï take a decision ð Those implementing acts shall be
adopted ï in accordance with the ð examination ï regulatory procedure
referred to in Article 21(2).

ê 1137/2008
Art. 1 and Annex, point 3.5.4 (adapted)

ð new

Article 19

Ö Adaptation
to technical progress Õ

The Commission shall ð adopt delegated acts in accordance
with Article 20 for the purpose of adapting ï adapt Annexes I to
VII to technical progress. Those measures,
designed to amend non-essential elements of this Directive, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in
Article 20a(3).

ò new

Article 20

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission
subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 10(4), Article
12(4) and Article 19 shall be conferred for an indeterminate period of
time from the [date of entry into force of this Directive]

ê 1137/2008
Art. 1 and Annex, point 3.5.4 (adapted)

ð new

3. The delegation of powers referred to in Article 10(4), Article 12(4)
and Article 19 may be revoked at any time by the European Parliament or by the
Council. A decision to revoke shall put an end to the delegation of the power
specified in that decision. It shall take effect the day following the
publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the
validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it
simultaneously to the European Parliament and to the Council.

5. A delegated act adopted pursuant to Article 10(4), Article 12(4) and
Article 19 shall enter into force only if no objection has been expressed
either by the European Parliament or the Council within a period of two months
of notification of that act to the European Parliament and the Council or
if, before the expiry of that period, the European Parliament and the Council have both
informed the Commission that they will not object. That period shall be
extended by one month at the initiative of the European Parliament or of the
Council.

ê 1137/2008
Art. 1 and Annex, point 3.5.5 (adapted)

ð new

Article 21

Ö Committee Õ

1. The Commission shall be assisted by the
committee established by Article 29(1) of Directive 67/548/EEC. ð That Committee shall be a Committee
within the meaning of Regulation (EU) No 182/2011. ï

2. Where reference is made to this
paragraph, ð Article 5 of Regulation (EU) No 182/2011
shall apply. ï Articles 5 and 7 of Decision 1999/468/EC
shall apply, having regard to the provisions of Article 8 thereof.

The period laid
down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference
is made to this paragraph, Article 5a(1) to (4) and Article 7 of
Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

ò new

Article 22

Repeal

Directive
1999/45/EC, as amended by the Acts listed in Part A of Annex VIII, is
repealed, without prejudice to the obligations of the Member States relating to
the time-limits for transposition into national law of the Directives set
out in Part B of Annex VIII to the repealed Directive and in
Part B of Annex VIII to this Directive.

References to the
repealed Directive shall be construed as references to this Directive and
shall be read in accordance with the correlation table in Annex IX.

ê 1999/45/EC
(adapted)

Article 23

Entry
into force

This Directive shall enter into force on
the Ö twentieth Õ day Ö following
that Õ of its
publication in the Official Journal of the European Union.

Article 24

Addressees

This
Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The
President                                                 The President

ê 1999/45/EC

ANNEX I

METHODS FOR THE EVALUATION OF
PHYSICO-CHEMICAL PROPERTIES OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 5

PART A

Exemptions to test methods of Part
A of the Annex to Regulation (EC) No 440/2008

See point 2.2.5 of Annex VI to
Directive 67/548/EEC.

PART B

Alternative calculation methods

B.1.        Non-gaseous preparations

1.           Method for the determination of
oxidising properties of preparations containing organic peroxides.

See point 2.2.2.1 of Annex VI to
Directive 67/548/EEC.

B.2.        Gaseous preparations

1.           Method for the determination of
oxidising properties

See point 9.1.1.2 of Annex VI to
Directive 67/548/EEC.

2.           Method for the determination of
flammability properties

See point 9.1.1.1 of Annex VI to
Directive 67/548/EEC.

_____________

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(c)

ANNEX II

METHODS FOR THE EVALUATION OF
HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 6

Introduction

An assessment must be made for all the
health effects corresponding to the health effects of substances contained in a
preparation. This conventional method described in Parts A and B of this
Annex is a calculation method which is applicable to all preparations and which
takes into consideration all the health hazards of substances contained in the
preparation. For that purpose the dangerous health effects have been subdivided
into:

1.           acute lethal effects;

2.           non-lethal irreversible effects
after a single exposure;

3.           severe effects after repeated or
prolonged exposure;

4.           corrosive effects, irritant
effects;

5.           sensitising effects;

6.           carcinogenic effects, mutagenic
effects, toxic effects for reproduction.

The health
effects of a preparation are to be assessed in accordance with
Article 6(1)(a) by the conventional method described in Parts A and B
of this Annex using individual concentration limits:

(a)          where the dangerous substances
listed in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç are assigned
concentration limits necessary for the application of the method of assessment
described in Part A of this Annex, these concentration limits must be
used;

(b)          where the dangerous substances do
not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear
there without the concentration limits necessary for the application of the
method of evaluation described in Part A of this Annex, the concentration
limits must be assigned in accordance with the specifications in Part B of
this Annex.

The procedure for classification is set out
in Part A of this Annex.

The
classification of the substance(s) and the resulting classification of the
preparation are expressed:

–
either by a symbol and one or more risk phrases,
or

–
by categories (category 1, category 2
or category 3) also assigned risk phrases when substances and preparations
are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it
is important to consider, in addition to the symbol, all the phrases denoting
specific risks which are assigned to each substance under consideration.

The systematic assessment of all the
dangerous health effects is expressed by means of concentration limits,
expressed as a weight/weight percentage except for gaseous preparations where
they are expressed as a volume/volume percentage and in conjunction with the
classification of the substance.

Where they are not given in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç, the
concentration limits to be taken into account for the application of this conventional
method are those set out in Part B of this Annex.

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), first indent

PART A

Procedure for evaluation of health
hazards

The evaluation proceeds stepwise as
follows:

1.           The following
preparations are to be classified as very toxic:

1.1.        owing to their acute lethal
effects and assigned the symbol ‘T+’, the indication of danger ‘very
toxic’ and the risk phrases R26, R27 or R28:

1.1.1.     preparations containing one or more
substances classified as very toxic that produce such effects, in individual
concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 1 in Part B of this Annex (Table 1 and 1a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

1.1.2.     preparations containing more than one
substance classified as very toxic in lower individual concentrations than the
limits specified in point 1.1.1(a) or (b) if:

where:

PT+ || = || is the percentage by weight or by volume of each very toxic substance in the preparation,

LT+ || = || is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by volume;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), second indent

1.2.        owing to their non-lethal
irreversible effects after a single exposure and assigned the symbol ‘T+’,
the indication of danger ‘very toxic’ and the risk phrase R39/route of
exposure.

Preparations containing at least one dangerous substance that
produces such effects in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 2 in Part B of this Annex (Table 2 and 2a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

2.           The following
preparations shall be classified as toxic:

2.1.        owing to their acute lethal
effects and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the
risk phrases R23, R24 or R25;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), third indent

2.1.1.     preparations containing one or more
substances classified as very toxic or toxic that produce such effects in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 1 in Part B of this Annex (Table 1 and 1a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

2.1.2.     preparations containing more than one
substance classified as very toxic or toxic in lower individual concentrations
than the limits specified in point 2.1.1(a) or (b) if:

where:

PT+ || = || is the percentage by weight or by volume of each very toxic substance in the preparation,

PT || = || is the percentage by weight or by volume of each toxic substance in the preparation,

LT || = || is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by weight or by volume;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), fourth indent

2.2         owing to their non-lethal
irreversible effects after a single exposure and assigned the symbol ‘T’, the
indication of danger ‘toxic’ and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance classified
as very toxic or toxic that produce such effects in individual concentrations
equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 2 in Part B of this Annex (Table 2 and 2a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), fifth indent

2.3.        owing to their long-term effects
and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk
phrase R48/route of exposure.

Preparations containing at least one dangerous substance that
produces such effects in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 3 in Part B of this Annex (Table 3 and 3a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

3.           The following
preparations shall be classified as harmful:

3.1.        owing to their acute lethal
effects and assigned the symbol ‘Xn’ and the indication of danger
‘harmful’ and the risk phrases R20, R21 or R22;

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(d), sixth indent

3.1.1.     preparations containing one or more
substances classified as very toxic, toxic or harmful and that produce such
effects in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at point 1
in Part B of this Annex (Table 1 and 1a) where the substance or
substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

3.1.2.     preparations containing more than one
substance classified as very toxic, toxic or harmful in lower individual
concentrations than the limits specified in point 3.1.1(a) or (b) if:

where:

PT+ || = || is the percentage by weight or by volume of each very toxic substance in the preparation,

PT || = || is the percentage by weight or by volume of each toxic substance in the preparation,

PXn || = || is the percentage by weight or by volume of each harmful substance in the preparation,

LXn || = || is the respective harmful limit specified for each very toxic, toxic or harmful substance, expressed as percentage by weight or by volume;

3.2.        owing to their acute effects to
the lungs if swallowed and assigned the symbol ‘Xn’, and the
indication of danger ‘harmful’ and the risk phrase R65.

Preparations classified as harmful according to
the criteria specified in point 3.2.3 of Annex VI to
Directive 67/548/EEC. In applying the conventional method according to point 3.1
Ö of this
Part Õ no account
shall be taken of the classification of a substance as R65;

ê 1999/45/EC

è1 2001/60/EC Art. 1 pt. 1, first indent

3.3.        owing to their non-lethal
irreversible effects after a single exposure and assigned the symbol ‘Xn’,
the indication of danger ‘harmful’ and the risk phrase è1 R68 ç/route of
exposure.

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), seventh indent

Preparations containing at least one dangerous substance classified
as very toxic, toxic or harmful that produces such effects in individual
concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 2 in Part B of this Annex (Table 2 and 2a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), eighth indent

3.4.        owing to their long-term effects
and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and
the risk phrase R48/route of exposure.

Preparations containing at least one dangerous substance classified
as toxic or harmful that produces such effects in individual concentrations
equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 3 in Part B of this Annex (Table 3 and 3a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

4.           The following
preparations are to be classified as corrosive:

4.1.        and assigned the symbol ‘C’, the
indication of danger ‘corrosive’ and the risk phrase R35;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), ninth indent

4.1.1.     preparations containing one or more
substances classified as corrosive to which is assigned the phrase R35 in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 4 in Part B of this Annex (Table 4 and 4a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

4.1.2.     preparations containing more than one
substance classified as corrosive to which is assigned phrase R35 in lower
individual concentrations than the limits specified in point 4.1.1(a) or (b)
if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in the preparation,

LC, R35 || = || is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35, expressed as a percentage by weight or by volume;

4.2.        and assigned the symbol ‘C’, the
indication of danger ‘corrosive’ and the risk phrase R34;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), tenth indent

4.2.1.     preparations containing one or more
substances classified as corrosive to which is assigned the phrase R35 or
R34 in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 4 in Part B of this Annex (Table 4 and 4a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

4.2.2.     preparations containing more than one of the
substances classified as corrosive to which is assigned the phrase R35 or
R34 in lower individual concentrations than the limits specified in point
4.2.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

LC, R34 || = || is the respective corrosive limit R34 specified for each corrosive substance to which is assigned phrase R35 or R34, expressed as a percentage by weight or by volume.

5.           The following
preparations are to be classified as irritants:

5.1.        liable to cause serious eye damage
and assigned the symbol ‘Xi’, the indication of danger ‘irritant’
and the risk phrase R41;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), eleventh indent

5.1.1.     preparations containing one or more
substances classified as irritant to which is assigned phrase R41 in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 4 in Part B of this Annex (Table 4 and 4a) where the substance
or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

5.1.2.     preparations containing more than one of the
substances classified as irritant and to which is assigned phrase R41, or
classified as corrosive and to which is assigned phrase R35 or R34, in
lower individual concentrations than the limits specified in point 5.1.1(a) or
(b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

LXi, R41 || = || is the respective irritant limit R41 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed as percentage by weight or by volume;

5.2.        irritant to eyes and assigned the
symbol ‘Xi’, the indication of danger ‘irritant’ and the risk
phrase R36;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), twelfth indent

5.2.1.     preparations containing one or more
substances classified as corrosive to which is assigned phrase R35 or R34
or as irritant and to which is assigned phrase R41 or R36 in individual
concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 4 in Part B of this Annex (Table 4 and 4a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

5.2.2.     preparations containing more than one
substance classified as irritant to which is assigned phrase R41 or R36,
or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in
point 5.2.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

PXi, R36 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R36 in the preparation,

LXi, R36 || = || is the respective irritant limit R36 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as percentage by weight or by volume;

5.3.        irritant to skin and assigned the
symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase
R38;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), thirteenth indent

5.3.1.     preparations containing one or more
substances classified as irritant and to which is assigned phrase R38 or
as corrosive and to which is assigned phrase R35 or R34 in individual
concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 4 in Part B of this Annex (Table 4 and 4a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

5.3.2.     preparations containing more than one of the
substances classified as irritant and to which is assigned phrase R38, or
as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the
limits specified in point 5.3.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R38 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38 in the preparation,

LXi, R38 || = || is the respective irritant limit R38 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by weight or by volume;

5.4.        irritant to respiratory system and
assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and
the risk phrase R37;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), fourteenth indent

5.4.1.     preparations containing one or more
substances classified as irritant and to which is assigned phrase R37 in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 4 in Part B of this Annex (Table 4 and 4a) where the
substance or the substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

5.4.2.     preparations containing more than one
substance classified as irritant and to which is assigned phrase R37 in
lower individual concentrations than the limits specified in point 5.4.1(a) or
(b) if:

where:

PXi, R37 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37 || = || is the irritant limit R37 specified for each irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume;

5.4.3.     gaseous preparations containing more than
one of the substances classified as irritant to which is assigned
phrase R37 or as corrosive and to which is assigned phrase R35 or R34
in lower individual concentrations than the limits specified in point 5.4.1(a)
or (b) if:

where:

PC, R35 || = || is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R37 || = || is the percentage by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37 || = || is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume.

6.           The following
preparations are to be classified as sensitising:

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), fifteenth indent

6.1.        by skin contact and assigned the
symbol ‘Xi’, the indication of danger ‘irritant’ and the risk
phrase R43.

Preparations containing at least one substance classified as
sensitising and to which is assigned phrase R43 that produces such effects
in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 5 in Part B of this Annex (Table 5 and 5a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), sixteenth indent

6.2.        by inhalation and assigned the
symbol ‘Xn’, the indication of danger ‘harmful’ and the risk
phrase R42.

Preparations containing at least one substance classified as
sensitising to which is assigned phrase R42 that produces such effects in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 5 in Part B of this Annex (Table 5 and 5a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

7.           The following
preparations are to be classified as carcinogenic:

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), seventeenth indent

7.1.        those of category 1 or 2
which are assigned the symbol ‘T’ and the phrase R45 or R49.

Preparations containing at least one substance producing such
effects, classified as carcinogenic and to which is assigned phrase R45 or
R49 which denotes carcinogenic substances in category 1 and
category 2, in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), eighteenth indent

7.2.        those of category 3 which are
assigned the symbol ‘Xn’ and the phrase R40.

Preparations containing at least one substance producing such
effects classified as carcinogenic and to which is assigned phrase R40
which denotes carcinogenic substances in category 3, in individual
concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the substance
or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

8.           The following
preparations are to be classified as mutagenic:

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), nineteenth indent

8.1.        those of category 1 or 2
which are assigned the symbol ‘T’ and the phrase R46.

Preparations containing at least one substance producing such
effects, classified as mutagenic and to which is assigned phrase R46 which
denotes mutagenic substances in category 1 and category 2, in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 2001/60/EC Art. 1 pt. 1, second indent

8.2.        those of category 3 which are
assigned the symbol ‘Xn’ and the phrase è1 R68 ç.

Preparations containing at least one substance, producing such
effects, classified as mutagenic and to which is assigned phrase è1 R68 ç which denotes
mutagenic substances in category 3, in individual concentrations equal to
or greater than:

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), twentieth indent

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

9.           The following
preparations are to be classified as toxic for reproduction:

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), twenty-first indent

9.1.        those of category 1 or 2
which are assigned the symbol ‘T’ and the phrase R60 (fertility).

Preparations containing at least one substance producing such
effects, classified as toxic for reproduction and to which is assigned
phrase R60 which denotes substances toxic for reproduction of
category 1 and category 2, in individual concentrations equal to or
greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), twenty-second indent

9.2.        those of category 3 which are
assigned the symbol ‘Xn’ and the phrase R62 (fertility).

Preparations containing at least one substance producing such
effects, classified as toxic for reproduction and to which is assigned
phrase R62 which denotes substances toxic for reproduction of
category 3, in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), twenty-third indent

9.3.        those of category 1 or 2
which are assigned the symbol ‘T’ and the phrase R61 (development).

Preparations containing at least one substance producing such
effects, classified as toxic for reproduction and to which is assigned
phrase R61 which denotes substances toxic for reproduction of
category 1 and category 2, in individual concentrations equal to or
greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the
substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), twenty-fourth indent

9.4.        those of category 3 which are
assigned the symbol ‘Xn’ and the phrase R63 (development).

Preparations containing at least one substance producing such
effects, classified as toxic for reproduction and to which is assigned
phrase R63 which denotes substances toxic for reproduction of
category 3, in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified at
point 6 in Part B of this Annex (Table 6 and 6a) where the substance
or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits.

ê 1999/45/EC (adapted)

è1 1272/2008 Art. 56 pt. 2(e)

PART
B

Concentration
limits to be used in evaluation of health hazards

For each
health effect, the first table (Tables 1 to 6) sets out the concentration
limits (expressed as a weight/weight percentage) to be used for non-gaseous
preparations and the second table (Tables 1a to 6a) sets out the
concentration limits (expressed as a volume/volume percentage) to be used for
gaseous preparations. These concentration limits are used in the absence of
specific concentration limits for the substance under consideration in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç.

1.           Acute lethal effects

1.1.        Non-gaseous preparations

The concentration limits fixed in Table 1,
expressed as a weight/weight percentage, determine the classification of the
preparation in relation to the individual concentration of the substance(s)
present whose classification is also shown.

Table 1

Classification of the substance || Classification of the preparation

T+ || T || Xn

T+ with R26, R27, R28 || concentration ≥ 7 % || 1 % ≤ concentration < 7 % || 0,1 % ≤ concentration < 1 %

T with R23, R24, R25 || || concentration ≥ 25 % || 3 % ≤ concentration < 25 %

Xn with R20, R21, R22 || || || concentration ≥ 25 %

The R phrases denoting risk are to be assigned to the
preparation in accordance with the following criteria:

–
the label shall include one or more of the
abovementioned R phrases according to the classification used,

–
in general, the R phrases selected should
be those applicable to the substance(s) present in the concentration which
gives rise to the most severe classification.

1.2.        Gaseous preparations

The concentration limits expressed as a
volume/volume percentage in Table 1a determine the classification of the
gaseous preparations in relation to the individual concentration of the gas(es)
present whose classification is also shown.

Table 1a

Classification of the substance (gas) || Classification of the gaseous preparation

T+ || T || Xn

T+ with R26, R27, R28 || concentration ≥ 1 % || 0,2 % ≤ concentration < 1 % || 0,02 % ≤ concentration < 0,2 %

T with R23, R24, R25 || || concentration ≥ 5 % || 0,5 % ≤ concentration < 5 %

Xn with R20, R21, R22 || || || concentration ≥ 5 %

The R phrases denoting risk shall be assigned to the
preparation in accordance with the following criteria:

–
the label shall include one or more of the
abovementioned R phrases according to the classification used,

–
in general, the R phrases selected should
be those applicable to the substance(s) present in the concentration which
gives rise to the most severe classification.

ê 1999/45/EC
(adapted)

è1 2001/60/EC Art. 1 pt. 2, first indent

è2 2001/60/EC Art. 1 pt. 2, second indent

2.           Non-lethal irreversible effects after a single exposure

2.1.        Non-gaseous preparations

For substances that produce non-lethal irreversible
effects after a single exposure (R39/route of exposure, è1 R68 ç/route of
exposure), the individual concentration limits specified in Table 2,
expressed as a weight/weight percentage, determine, when appropriate, the classification
of the preparation.

Table 2

Classification of the substance || Classification of the preparation

T+ || T || Xn

T+ with R39/route of exposure || concentration ≥ 10 % R39 (*) obligatory || 1 % ≤ concentration < 10 % R39 (*) obligatory || 0,1 % ≤ concentration < 1 % è1 R68 ç (*) obligatory

T with R39/route of exposure || || concentration ≥ 10 % R39 (*) obligatory || 1 % ≤ concentration < 10 % è1 R68 ç (*) obligatory

Xn with è1 R68 ç/route of exposure || || || concentration ≥ 10 % è1 R68 ç (*) obligatory

(*)               In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

2.2.        Gaseous preparations

For gases that produce non-lethal irreversible
effects after a single exposure (R39/route of exposure, è2 R68 ç/route of
exposure), the individual concentration limits specified in Table 2a,
expressed as a volume/volume percentage, determine, when appropriate, the
classification of the preparation.

Table 2a

Classification of the substance (gas) || Classification of the gaseous preparation

T+ || T || Xn

T+ with R39/route of exposure || concentration ≥ 1 % R39 (*) obligatory || 0,2 % ≤ concentration < 1 % R39 (*) obligatory || 0,02 % ≤ concentration < 0,2 % è2 R68 ç (*) obligatory

T with R39/route of exposure || || concentration ≥ 5 % R39 (*) obligatory || 0,5 % ≤ concentration < 5 % è2 R68 ç (*) obligatory

Xn with è2 R68 ç/route of exposure || || || concentration ≥ 5 % è2 R68 ç (*) obligatory

(*)               In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

3.           Severe effects after repeated or prolonged exposure

3.1.        Non-gaseous preparations

For substances that produce severe effects
after repeated or prolonged exposure (R 48/route of exposure), the
individual concentration limits specified in Table 3, expressed as a
weight/weight percentage, determine, when appropriate, the classification of
the preparation.

Table 3

Classification of the substance || Classification of the preparation

T || Xn

T with R48/route of exposure || concentration ≥ 10 % R48 (*) obligatory || 1 % ≤ concentration < 10 % R48 (*) obligatory

Xn with R48/route of exposure || || concentration ≥ 10 % R48 (*) obligatory

(*)               In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

3.2.        Gaseous preparations

For gases that produce severe effects after
repeated or prolonged exposure (R48/route of exposure), the individual
concentration limits specified in Table 3a, expressed as a volume/volume
percentage, determine, when appropriate, the classification of the preparation.

Table 3a

Classification of the substance (gas) || Classification of the gaseous preparation

T || Xn

T with R48/route of exposure || concentration ≥ 5 % R48 (*) obligatory || 0,5 % ≤ concentration < 5 % R48 (*) obligatory

Xn with R48/route of exposure || || concentration ≥ 5 % R48 (*) obligatory

(*)               In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

4.           Corrosive and irritant effects including serious damage
to the eye

4.1.        Non-gaseous preparations

For substances that produce corrosive effects
(R34, R35) or irritant effects (R36, R37, R38, R41), the individual
concentration limits specified in Table 4, expressed as a weight/weight
percentage, determine, when appropriate, the classification of the preparation.

Table 4

Classification of the substance || Classification of the preparation

C with R35 || C with R34 || Xi with R41 || Xi with R36, R37, R38

C with R35 || concentration ≥ 10 % R35 obligatory || 5 % ≤ concentration < 10 % R34 obligatory || 5 % (*) || 1 % ≤ concentration < 5 % R36/38 obligatory

C with R34 || || concentration ≥ 10 % R34 obligatory || 10 % (*) || 5 % ≤ concentration < 10 % R36/38 obligatory

Xi with R41 || || || concentration ≥ 10 % R41 obligatory || 5 % ≤ concentration < 10 % R36 obligatory

Xi with R36, R37, R38 || || || || concentration ≥ 20 % R36, R37, R38 are obligatory in the light of the concentration present if they apply to the substances under consideration

(*)               According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36.

ê 2001/60/EC
Art. 1 pt 3

NB:            Simple application of the conventional
method to preparations containing substances classified as corrosive or
irritant may result in under-classification or over-classification of the
hazard, if other relevant factors (e.g. pH of the preparation) are not taken
into account. Therefore, in classifying for corrosivity, consider the advice
given in point 3.2.5 of Annex VI to Directive 67/548/EEC
and in the second and third indents of Article 6(3), of this Directive.

ê 1999/45/EC
(adapted)

4.2.        Gaseous preparations

For gases that produce such effects (R34, R35
or R36, R37, R38, R41), the individual concentration limits specified in
Table 4a, expressed as a volume/volume percentage determine, when
appropriate, the classification of the preparation.

Table 4a

Classification of the substance (gas) || Classification of the gaseous preparation

C with R35 || C with R34 || Xi with R41 || Xi with R36, R37, R38

C with R35 || concentration ≥ 1 % R35 obligatory || 0,2 % ≤ concentration < 1 % R34 obligatory || 0,2 % (*) || 0,02 % ≤ concentration < 0,2 % R36/37/38 obligatory

C with R34 || || concentration ≥ 5 % R34 obligatory || 5 % (*) || 0,5 % ≤ concentration < 5 % R36/37/38 obligatory

Xi with R41 || || || concentration ≥ 5 % R41 obligatory || 0,5 % ≤ concentration < 5 % R36 obligatory

Xi with R36, R37, R38 || || || || concentration ≥ 5 % R36, R37, R38 obligatory as appropriate

(*)               According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36.

ê 2001/60/EC
Art. 1 pt. 3

NB:            Simple application of the conventional
method to preparations containing substances classified as corrosive or
irritant may result in under-classification or over-classification of the
hazard, if other relevant factors (e.g. pH of the preparation) are not taken
into account. Therefore, in classifying for corrosivity, consider the advice
given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and
third indents of Article 6(3), of this Directive.

ê 1999/45/EC
(adapted)

è1 2001/60/EC Art. 1 pt. 2, third indent

5.           Sensitising effects

5.1.        Non-gaseous preparations

Preparations that produce such effects are classified as sensitising
and assigned:

–
the symbol Xn and phrase R42 if
this effect can be produced by inhalation,

–
the symbol Xi and phrase R43 if
this effect can be produced through contact with the skin.

The individual concentration limits specified
in Table 5, expressed as a weight/weight percentage, determine, when
appropriate, the classification of the preparation.

Table 5

Classification of the substance || Classification of the preparation

Sensitising with R42 || Sensitising with R43

Sensitising with R42 || concentration ≥ 1 % R42 obligatory ||

Sensitising with R43 || || concentration ≥ 1 % R43 obligatory

5.2.        Gaseous preparations

Gaseous preparations that produce such effects
are classified as sensitising and assigned:

–
the symbol Xn and phrase R42 if
this effect can be produced by inhalation,

–
the symbol Xi and phrase R43 if
this effect can be produced through contact with the skin.

The individual concentration limits specified
in Table 5a, expressed as a volume/volume percentage, determine, when
appropriate, the classification of the preparation.

Table 5a

Classification of the substance (gas) || Classification of the gaseous preparation

Sensitising with R42 || Sensitising with R43

Sensitising with R42 || concentration ≥ 0,2 % R42 obligatory ||

Sensitising with R43 || || concentration ≥ 0,2 % R43 obligatory

6.           Carcinogenic/mutagenic/toxic effects for reproduction

6.1.        Non-gaseous preparations

For substances which produce such effects, the
concentration limits laid down in Table 6, expressed as a weight/weight
percentage, shall determine, where appropriate, the classification of the
preparation. The following symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2: || T; R45 or R49

Carcinogenic category 3: || Xn; R40

Mutagenic categories 1 and 2: || T; R46

Mutagenic category 3: || Xn; è1 R68 ç

Toxic for reproduction fertility categories 1 and 2: || T; R60

Toxic for reproduction development categories 1 and 2: || T; R61

Toxic for reproduction fertility category 3: || Xn; R62

Toxic for reproduction development category 3: || Xn; R63

ê 2006/8/EC
Art. 1 and Annex, pt. 1(a)

Table 6

Classification of the substance || Classification of the preparation

Categories 1 and 2 || Category 3

Carcinogenic substances of category 1 or 2 with R45 or R49 || Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate ||

Carcinogenic substances of category 3 with R40 || || Concentration ≥ 1 % carcinogenic R40 obligatory (unless already assigned R45 (*))

Mutagenic substances of category 1 or 2 with R46 || Concentration ≥ 0,1 % mutagenic R46 obligatory ||

Mutagenic substances of category 3 with R68 || || Concentration ≥ 1 % mutagenic R68 obligatory (unless already assigned R46)

Substances ‘toxic for reproduction’ of category 1 or 2 with R60 (fertility) || Concentration ≥ 0,5 % toxic for reproduction (fertility) R60 obligatory ||

Substances ‘toxic for reproduction’ of category 3 with R62 (fertility) || || Concentration ≥ 5 % toxic for reproduction (fertility) R62 obligatory (unless already assigned R60)

Substances ‘toxic for reproduction’ of category 1 or 2 with R61 (development) || Concentration ≥ 0,5 % toxic for reproduction (development) R61 obligatory ||

Substances ‘toxic for reproduction’ of category 3 with R63 (development) || || Concentration ≥ 5 % toxic for reproduction (development) R63 obligatory (unless already assigned R61)

(*)               In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.

ê 1999/45/EC

è1 2001/60/EC Art. 1 pt. 2, fifth indent

6.2.        Gaseous preparations

For gases which produce such effects, the
concentration limits laid down in Table 6a, expressed as a volume/volume
percentage, shall determine, where appropriate, the classification of the
preparation. The following symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2: || T; R45 or R49

Carcinogenic category 3: || Xn; R40

Mutagenic categories 1 and 2: || T; R46

Mutagenic category 3: || Xn; è1 R68 ç

Toxic for reproduction fertility categories 1 and 2: || T; R60

Toxic for reproduction development categories 1 and 2: || T; R61

Toxic for reproduction fertility category 3: || Xn; R62

Toxic for reproduction development category 3: || Xn; R63

ê 2006/8/EC
Art. 1 and Annex, pt. 1(b)

Table 6a

Classification of the substance || Classification of the preparation

Categories 1 and 2 || Category 3

Carcinogenic substances of category 1 or 2 with R45 or R49 || Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate ||

Carcinogenic substances of category 3 with R40 || || Concentration ≥ 1 % carcinogenic R40 obligatory (unless already assigned R45 (*))

Mutagenic substances of category 1 or 2 with R46 || Concentration ≥ 0,1 % mutagenic R46 obligatory ||

Mutagenic substances of category 3 with R68 || || Concentration ≥ 1 % mutagenic R68 obligatory (unless already assigned R46)

Substances ‘toxic for reproduction’ of category 1 or 2 with R60 (fertility) || Concentration ≥ 0,2 % toxic for reproduction (fertility) R60 obligatory ||

Substances ‘toxic for reproduction’ of category 3 with R62 (fertility) || || Concentration ≥ 1 % toxic for reproduction (fertility) R62 obligatory (unless already assigned R60)

Substances ‘toxic for reproduction’ of category 1 or 2 with R61 (development) || Concentration ≥ 0,2 % toxic for reproduction (development) R61 obligatory ||

Substances ‘toxic for reproduction’ of category 3 with R63 (development) || || Concentration ≥ 1 % toxic for reproduction (development) R63 obligatory (unless already assigned R61)

(*)               In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.

_____________

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(f)

è2 Corrigendum
1999/45/EC (OJ L 6, 10.1.2002, p. 70)

è3 1272/2008 Art. 56 pt. 2(g),
first indent

ANNEX III

METHODS FOR THE EVALUATION OF THE
ENVIRONMENTAL HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 7

Introduction

The systematic assessment of all the
dangerous properties for the environment is expressed by means of concentration
limits, expressed as a weight/weight percentage except for gaseous preparations
where they are expressed as a volume/volume percentage and in conjunction with
the classification of a substance.

Part A gives the calculation procedure
according to Article 7(1)(a) and gives the R phrases to be assigned to the
classification of the preparation.

Part B gives the concentration limits to be
used when applying the conventional method and relevant symbols and R phrases
for classification.

In accordance with Article 7(1)(a) the
environmental hazards of a preparation shall be assessed by the conventional
method described in Parts A and B of this Annex, using individual
concentration limits.

(a)          Where the dangerous substances
listed in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç are assigned
concentration limits necessary for the application of the method of assessment
described in Part A of this Annex, these concentration limits must be
used.

(b)          Where the dangerous substances do
not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear
there without the concentration limits necessary for the application of the
method of evaluation described in Part A of this Annex, the concentration
limits shall be assigned in accordance with the specification in Part B of
this Annex.

Part C gives the test methods for the
evaluation of the hazards for the aquatic environment.

PART
A

Procedure
for the evaluation of environmental hazards

(a)          Aquatic environment

I.            Conventional method for
the evaluation of hazards to the aquatic environment

The conventional method for the evaluation of
hazards to the aquatic environment è2 takes into account all the hazards that a
preparation may entail ç for this
medium according to the following specifications.

The following preparations are to be classified as dangerous for the
environment:

1.      and assigned the symbol ‘N’, the
indication of danger ‘dangerous for the environment’ and the risk phrases R50
and R53 (R50-53):

1.1.    preparations containing one or more substances classified as
dangerous to the environment and to which is assigned phrases R50-53 in
individual concentrations equal to or greater than:

(a)     either the concentration specified in è3 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in
Part B of this Annex (Table 1) where the substance or substances do not
appear in è3 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

1.2.    preparations containing more than one substance classified
as dangerous for the environment and to which is assigned phrases R50–53 in
lower individual concentrations than the limits specified in point I.1.1(a) or
(b) if:

where:

PN, R50—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

LN, R50—53 || = || is the limit R50–53 for each substance dangerous for the environment to which is assigned the phrases R50–53, expressed as percentage by weight;

2.      and assigned the symbol ‘N’, the
indication of danger ‘dangerous for the environment’ and the risk phrases R51
and R53 (R51–53) unless the preparation is already classified according to point
I.1;

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(g),
second indent

2.1.    preparations containing one or more than one substance
classified as dangerous to the environment and to which is assigned phrases R50–53
or R51–53 in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in Part B
of this Annex (Table 1) where the substance or substances do not appear in
è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

2.2.    preparations containing more than one of the substances
classified as dangerous for the environment and to which is assigned phrases
R50–53 or R51–53 in lower individual concentrations than the limits specified in
point I.2.1 (a) or (b) if:

where:

PN, R50—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

PN, R51—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51–53 in the preparation,

LN, R51—53 || = || is the respective limit R51–53 for each substance dangerous for the environment to which is assigned phrases R50–53 or R51–53, expressed as percentage by weight;

3.      and assigned the risk phrases R52 and
R53 (R52–53) unless the preparation is already classified according to point
I.1 or I.2;

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(g),
third indent

3.1.    preparations containing one or more than one substance
classified as dangerous to the environment and to which is assigned phrases R50–53
or R51–53 or R52–53 in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in
Part B of this Annex (Table 1) where the substance or substances do
not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

3.2.    preparations containing more than one of the substances
classified as dangerous for the environment and to which is assigned phrases
R51–53 or R50–53 or R52–53 in lower individual concentrations than the limits
specified in point I.3.1(a) or (b) if:

where:

PN, R50—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

PN, R51—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51–53 in the preparation,

PR52—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52–53 in the preparation,

LR52—53 || = || is the respective limit R52–53 for each substance dangerous for the environment to which is assigned phrases R50–53 or R51–53 or R52–53, expressed as percentage by weight;

4.      and assigned the symbol ‘N’, the
indication of danger ‘dangerous for the environment’ and the risk phrase R50
unless the preparation is already classified according to point I.1:

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(g),
fourth indent

4.1.    preparations containing one or more than one substance
classified as dangerous to the environment and to which is assigned phrase R50
in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in
Part B of this Annex (Table 2) where the substance or substances do
not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

4.2.    preparations containing more than one substance classified
as dangerous for the environment and to which is assigned phrase R50 in lower
individual concentrations than the limits specified in point I.4.1(a) or
(b) if:

where:

PN, R50 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

LN, R50 || = || is the limit R50 for each substance dangerous for the environment to which is assigned phrase R50, expressed as percentage by weight;

4.3.    preparations containing one or more than one of the
substances classified as dangerous for the environment and to which is assigned
phrase R50 not meeting the criteria in point I.4.1 or I.4.2 and containing
one or more than one substance classified as dangerous for the environment and
to which is assigned phrases R50–53 if:

where:

PN, R50 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

PN, R50—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,

LN, R50 || = || is the perspective limit R50 for each substance dangerous for the environment to which is assigned phrases R50 or R50–53, expressed as percentage by weight;

5.      and assigned the risk phrase R52
unless the preparation is already classified according to point I.1, I.2, I.3,
or I.4:

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(g),
fifth indent

5.1.    preparations containing one or more than one substance
classified as dangerous to the environment and to which is assigned phrase R52
in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in
Part B of this Annex (Table 3) where the substance or substances do
not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

5.2.    preparations containing more than one substance classified
as dangerous for the environment and to which is assigned phrase R52 in lower
individual concentrations than the limits specified in point I.5.1 (a) or
(b) if:

where:

PR52 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation,

LR52 || = || is the limit R52 for each substance dangerous for the environment to which is assigned phrase R52, expressed as percentage by weight;

6.       and assigned the risk phrase R53 unless the preparation is
already classified according to point I.1, I.2, or I.3 :

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(g),
sixth indent

6.1.    preparations containing one or more than one substance
classified as dangerous to the environment and to which is assigned phrase R53
in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in
Part B of this Annex (Table 4) where the substance or substances do
not appear in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç or appear in
it without concentration limits;

6.2.    preparations containing more than one substance classified
as dangerous for the environment and to which is assigned phrase R53 in lower
individual concentrations than the limits specified in point I.6.1(a) or
(b) if:

where:

PR53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

LR53 || = || is the limit R53 for each substance dangerous for the environment to which is assigned phrase R53, expressed as percentage by weight;

6.3.    preparations containing one or more than one of the
substances classified as dangerous for the environment and to which is assigned
phrase R53 not meeting the criteria in point I.6.2 and containing one or more
than one substance classified as dangerous for the environment and to which is
assigned phrases R50–53 or R51–53 or R52–53 if:

where:

PR53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

PN, R50—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50–53 in the preparation,

PN, R51—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R51–53 in the preparation,

PR52—53 || = || is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52–53 in the preparation,

LR53 || = || is the respective limit R53 for each substance dangerous for the environment to which is assigned phrase R53 or R50–53 or R51–53 or R52–53, expressed as percentage by weight.

(b)          Non-aquatic
environment

(1)          OZONE LAYER

I.            Conventional method for
the evaluation of preparations dangerous for the ozone layer

The following preparations Ö shall
be Õ classified as
dangerous for the environment:

1.      and assigned the symbol ‘N’, the
indication of danger ‘dangerous for the environment’ and the risk phrase R59;

ê 1999/45/EC

è1 1272/2008
Art. 56 pt. 2(h)

1.1.    preparations containing one or more substances classified as
dangerous to the environment and to which is assigned the symbol ‘N’ and the
risk phrase R59 in individual concentrations equal to or greater than:

(a)     either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç for the
substance or substances under consideration, or

(b)     the concentration specified in
Part B of this Annex (Table 5) where the substance or substances do
not appear in è1 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 ç or appear in
it without concentration limits.

(2)          TERRESTRIAL ENVIRONMENT

I.            Evaluation of
preparations dangerous for the terrestrial environment

Classification of preparations using the risk
phrases below will follow after the detailed criteria for use of the phrases
have been incorporated in Annex VI to Directive 67/548/EEC.

R54 || || Toxic to flora

R55 || || Toxic to fauna

R56 || || Toxic to soil organisms

R57 || || Toxic to bees

R58 || || May cause long-term adverse effects in the environment.

PART
B

Concentration
limits to be used for the evaluation of environmental hazards

I.            For the aquatic environment

The concentration limits fixed in the following
tables, expressed as a weight/weight percentage, determine the classification
of the preparation in relation to the individual concentration of the
substance(s) present whose classification is also shown.

ê 2006/8/EC
Art. 1 and Annex, pt. 2(b)

Table 1a

Acute aquatic toxicity and long-term adverse effects

Classification of the substance || Classification of the preparation

N, R50-53 || N, R51-53 || R52-53

N, R50-53 || see Table 1b || see Table 1b || see Table 1b

N, R51-53 || || Cn ≥ 25 % || 2,5 % ≤ Cn< 25 %

R52-53 || || || Cn ≥ 25 %

Preparations containing a substance classified
with N, R50–53, the concentration limits and the resulting classification given
in table 1b are applicable.

Table 1b

Acute aquatic toxicity and long-term adverse effects of substances very toxic to the aquatic environment

LC50 or EC50 value (‘L(E)C50’) of substance classified as N, R50–53 (mg/l) || Classification of the preparation

N, R50-53 || N, R51-53 || R52-53

0,1 < L(E)C50 ≤ 1 || Cn ≥ 25 % || 2,5 % ≤ Cn< 25 % || 0,25 % ≤ Cn< 2,5 %

0,01 < L(E)C50 ≤ 0,1 || Cn ≥ 2,5 % || 0,25 % ≤ Cn< 2,5 % || 0,025 % ≤ Cn< 0,25 %

0,001 < L(E)C50 ≤ 0,01 || Cn ≥ 0,25 % || 0,025 % ≤ Cn< 0,25 % || 0,0025 % ≤ Cn< 0,025 %

0,0001 < L(E)C50 ≤ 0,001 || Cn ≥ 0,025 % || 0,0025 % ≤ Cn< 0,025 % || 0,00025 % ≤ Cn< 0,0025 %

0,00001 < L(E)C50 ≤ 0,0001 || Cn ≥ 0,0025 % || 0,00025 % ≤ Cn< 0,0025 % || 0,000025 % ≤ Cn< 0,00025 %

For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentrationlimits are calculated accordingly (in factor 10 intervals).

ê 2006/8/EC
Art. 1 and Annex, pt. 2(c)

Table 2

Acute aquatic toxicity

LC50 or EC50 value (‘L(E)C50’) of substance classified either as N, R50 or as N, R50-53 (mg/l) || Classification of the preparation N, R50

0,1 < L(E)C50 ≤ 1 || Cn ≥ 25 %

0,01 < L(E)C50 ≤ 0,1 || Cn ≥ 2,5 %

0,001 < L(E)C50 ≤ 0,01 || Cn ≥ 0,25 %

0,0001 < L(E)C50 ≤ 0,001 || Cn ≥ 0,025 %

0,00001 < L(E)C50 ≤ 0,0001 || Cn ≥ 0,0025 %

For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentration limits are calculated accordingly (in factor 10 intervals).

ê 1999/45/EC
(adapted)

Table 3

Aquatic toxicity

Classification of the substance || Classification of the preparation R52

R52 || Cn ≥ 25 %

Table 4

Long-term adverse effects

Classification of the substance || Classification of the preparation R53

R53 || Cn ≥ 25 %

N, R50—53 || Cn ≥ 25 %

N, R51—53 || Cn ≥ 25 %

R52—53 || Cn ≥ 25 %

II.          For the non-aquatic environment

The concentration limits fixed in the following
tables, expressed as weight/weight percentage or, for gaseous preparations as a
volume/volume percentage, determine the classification of the preparation in
relation to the individual concentration of the substance(s) present whose
classification is also shown.

ê 2006/8/EC
Art. 1 and Annex, pt. 2(d)

Table 5

Dangerous for the ozone layer

Classification of the substance || Classification of the preparation N, R59

N with R59 || Cn ≥ 0,1 %

ê 1999/45/EC
(adapted)

PART
C

Test
methods for the evaluation of the hazards for the aquatic environment

Normally, the classification of a
preparation is made on the basis of the conventional method. However, for the
determination of the acute aquatic toxicity, there may be cases for which it is
appropriate to carry out tests on the preparation.

The result of these tests on the
preparation may only modify the classification concerning acute aquatic
toxicity which would have been obtained by the application of the conventional
method.

If such tests are chosen by the person
responsible for the placing on the market, it must be ensured that the quality
criteria of the test methods in Part C Ö of the
Annex to Õ Regulation
(EC) No 440/2008 have been complied with.

Furthermore, the tests are to be carried
out on all three species in conformity with the criteria of Annex VI to
Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard
classification relating to acute aquatic toxicity has been assigned to the
preparation after testing on one of the species or a test result was already
available before this Directive entered into force.

_____________

ANNEX IV

SPECIAL PROVISIONS FOR CONTAINERS
CONTAINING PREPARATIONS OFFERED OR SOLD TO THE GENERAL PUBLIC

PART A

Containers to be fitted with
child-resistant fastenings

1.           Containers of whatever capacity,
containing preparations offered or sold to the general public and labelled as
very toxic, toxic or corrosive in accordance with Article 10 and under the
conditions laid down in Article 6, are to Ö be Õ fitted with
child-resistant fastenings.

2.           Containers of whatever capacity
containing preparations presenting an aspiration hazard (Xn, R65)
and classified and labelled according to point 3.2.3 of Annex VI to
Directive 67/548/EEC with the exception of preparations placed on the
market in the form of aerosols or in a container fitted with a sealed spray
attachment.

3.           Containers of whatever capacity,
having at least one of the substances mentioned below present in a
concentration equal to or greater then the maximum individual concentration
specified,

No || Identification of the substance || Concentration limit

CAS-Reg No || Name || Einecs No

1 || 67-56-1 || Methanol || 2006596 || ≥ 3 %

2 || 75-09-2 || Dichloromethane || 2008389 || ≥ 1 %

which are offered or sold to the general public
are to be fitted with child-resistant fastenings.

PART
B

Containers
to be fitted with a tactile warning of danger

Containers of whatever capacity, containing
preparations offered or sold to the general public and labelled as very toxic,
toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Article 10
and under the conditions laid down in Articles 5 and 6,are to
carry a tactile warning of danger.

This provision does not apply to aerosols
classified and labelled only as extremely flammable or highly flammable.

_____________

ê 2006/8/EC
Art. 1 and Annex, pt. 3

è1 1272/2008 Art. 56 pt. 2(i)

è2 Corrigendum 2006/8/EC (OJ L 43, 15.2.2007, p. 42)

è3 1272/2008 Art. 56 pt. 2(j)

ANNEX V

SPECIAL PROVISIONS CONCERNING THE
LABELLING OF CERTAIN PREPARATIONS

A.           For preparations classified as dangerous within the meaning of Articles
5, 6 and 7

1.           Preparations sold to the
general public

1.1.        The label on the packaging
containing such preparations, in addition to the specific safety advice, must
bear the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria
laid down in Annex VI to Directive 67/548/EEC.

1.2.        When such preparations are
classified as very toxic (T+), toxic (T) or corrosive (C) and where it is
physically impossible to give such information on the package itself, packages
containing such preparations must be accompanied by precise and easily
understandable instructions for use including, where appropriate, instructions
for the destruction of the empty package.

2.           Preparations intended for
use by spraying

The label on the packaging containing such
preparations must compulsorily bear the safety advice S23 accompanied by safety
advice S38 or S51 assigned to it in accordance with the criteria laid down in
Annex VI to Directive 67/548/EEC.

3.           Preparations containing a
substance assigned phrase R33: Danger of cumulative effects

When a preparation contains at least one
substance assigned the phrase R33, the label on the packaging of the
preparation must carry the wording of this phrase as set out in Annex III
to Directive 67/548/EEC, when the concentration of this substance present in
the preparation is equal to or higher than 1 %, unless different values
are set in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç.

4.           Preparations containing a
substance assigned phrase R64: May cause harm to breastfed babies

When a preparation contains at least one
substance assigned phrase R64, the label on the packaging of the preparation
must carry the wording of this phrase as set out in Annex III to Directive
67/548/EEC, when the concentration of this substance present in the preparation
is equal to or higher than 1 %, unless different values are set in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç.

B.           For preparations irrespective of their classification
within the meaning of Articles 5, 6 and 7

1.           Preparations containing
lead

1.1.        Paint and varnishes

The label on the packaging of paints and
varnishes containing lead in quantities exceeding 0,15 % (expressed as
weight of metal) of the total weight of the preparation, as determined in
accordance with ISO standard 6503/1984, must show the following particulars:

‘Contains lead. Should not be used on surfaces
liable to be chewed or sucked by children’.

In the case of packages the contents of which
are less than 125 millilitres, the particulars may be as follows:

‘Warning! Contains lead’.

2.           Preparations containing
cyanoacrylates

2.1.        Adhesives

The label on the immediate packaging of
adhesives based on cyanoacrylate must bear the following inscriptions:

‘Cyanoacrylate.

Danger.

Bonds skin and eyes in seconds.

Keep out of the reach of children’.

Appropriate advice on safety must accompany the
package.

3.           Preparations containing
isocyanates

The label on the packaging of preparations
containing isocyanates (as monomers, oligomers, prepolymers, etc., or as
mixtures thereof) must bear the following inscriptions:

‘Contains isocyanates.

See information supplied by the manufacturer’.

4.           Preparations containing
epoxy constituents with an average molecular weight ≤ 700

The label on the packaging of preparations containing epoxy
constituents with an average molecular weight ≤ 700 must bear the
following inscriptions:

‘Contains epoxy constituents.

See information supplied by the manufacturer’.

5.           Preparations sold to
the general public which contain active chlorine

The label on the packaging of preparations
containing more than 1 % of active chlorine must bear the following
particular inscriptions:

‘Warning! Do not use together with other
products. May release dangerous gases (chlorine)’.

6.           Preparations
containing cadmium (alloys) and intended to be used for brazing or soldering

The label on the packaging of the above
mentioned preparations must bear the following inscription printed in clearly
legible and indelible characters:

‘Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the
manufacturer.

Comply with the safety instructions’.

7.           Preparations available
as aerosols

Without prejudice to the provisions of
this Directive, preparations available as aerosols are also subject to the
labelling provisions in accordance with points 2.2 and 2.3 of the
Annex to Directive 75/324/EEC.

8.           Preparations
containing substances not yet tested completely

Where a preparation contains at least one
substance which, in accordance with Directive 67/548/EEC, bears the inscription
è2 ‘Caution — substance not yet fully tested’, ç the label on
the packaging of the preparation must bear the inscription

‘Warning — this preparation contains a
substance not yet tested completely’ if this substance is present in a
concentration ≥ 1 %.

9.           Preparations not
classified as sensitising but containing at least one sensitising substance

The label on the
packaging of preparations containing at least one substance classified as
sensitising and being present in a concentration equal to or greater than 0,1 %
or in a concentration equal to or greater than that specified under a specific
note for the substance in è3 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç must bear the
inscription:

‘Contains (name of
sensitising substance). May produce an allergic reaction’.

10.         Liquid preparations
containing halogenated hydrocarbons

For liquid preparations which show no
flashpoint or a flashpoint higher than 55 °C and contain a halogenated
hydrocarbon and more than 5 % flammable or highly flammable substances,
the label on the packaging must bear the following inscription as appropriate:

‘Can become highly flammable in use’ or ‘Can
become flammable in use’.

11.         Preparations
containing a substance assigned phrase R67: vapours may cause drowsiness and
dizziness

When a preparation contains one or more
substances assigned the phrase R67, the label on the packaging of the
preparation must carry the wording of this phrase as set out in Annex III
to Directive 67/548/EEC, when the total concentration of these substances
present in the preparation is equal to or higher than 15 %, unless:

–
the preparation is already classified with
phrases R20, R23, R26, R68/20, R39/23 or R39/26,

–
or the preparation is in a package not exceeding
125 ml.

12.         Cements
and cement preparations

The label on the packaging of cements and
cement preparations containing more than 0,0002 % soluble chromium
(VI) of the total dry weight of the cement must bear the inscription:

‘Contains chromium (VI). May produce an
allergic reaction’

unless the preparation is already
classified and labelled as a sensitiser with phrase R43.

C.           For
preparations not classified within the meaning of Articles 5, 6 and 7 but
containing at least one dangerous substance

1.           Preparations
not intended for the general public

The label on the packaging of
preparations referred to in Article 31(3)(a) and (c) of Regulation (EC) No 1907/2006 must bear the following inscription:

‘Safety data sheet available for professional user on request’.

_____________

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt. 2(k)

ANNEX VI

CONFIDENTIALITY FOR THE CHEMICAL
IDENTITY OF A SUBSTANCE

PART A

Information to be communicated in
the request for confidentiality

Introductory notes

A.           Article 14 indicates the
conditions in which the person responsible for placing a preparation on the
market may avail himself of the confidentiality.

B.           To avoid multiple requests for
confidentiality relating to the same substance used in different preparations,
a single request for confidentiality may suffice if a certain number of
preparations have:

–
the same dangerous constituents present in the
same concentration range,

–
the same classification and labelling,

–
the same expected uses.

A single alternative denomination must be used
to mask the chemical identity of the same substance in the preparations
concerned. Furthermore, the request for confidentiality must contain all
information indicated in the following request, without forgetting the name or
the trade name of each preparation.

C.           The alternative designation used
on the label must be the same as that given under Heading 3 ‘Composition/information
on ingredients’ of Ö Annex II Õ to Regulation
(EC) No 1907/2006.

This implies that the alternative designation
used will contain enough information about the substance to ensure risk-free
handling.

D.           In making the request to use an
alternative designation the person responsible for placing on the market must
take into account the need to provide enough information for necessary health
and safety precautions to be taken in the workplace and to ensure that risks
from handling the preparation can be minimised.

Request for confidentiality

In accordance with Article 14 the
request for confidentiality must obligatorily contain the following
information:

1.           Name and full address (including
telephone number) of the person established in the Ö Union Õ who is
responsible for placing the preparation on the market (manufacturer, importer
or distributor).

2.           Precise identification of the
substance(s) for which confidentiality is proposed and the alternative
designation.

CAS No || Einecs No || Chemical name according to international nomenclature and classification (è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or provisional classification) || Alternative designation

(a) || ||

(b) || ||

(c) || ||

NB:            Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as evidence that the provisional classification takes account of all existing pertinent information available on the properties of the substance.

3.           Justification for confidentiality
(probability — plausibility).

4.           Designation(s) or commercial
name(s) of the preparation(s).

5.           Is the designation or commercial
name the same for all the Ö Union Õ?

YES || NO

If no, specify the designation(s) or commercial
name(s) used in the different Member States:

ê 2006/96/EC
Art. 1 and Annex, pt. G

Belgium:

Bulgaria:

Czech Republic:

Denmark:

Germany:

Estonia:

Ireland:

Greece:

Spain:

France:

Italy:

Cyprus:

Latvia:

Lithuania:

Luxembourg:

Hungary:

Malta:

Netherlands:

Austria:

Poland:

Portugal:

Romania:

Slovenia:

Slovakia:

Finland:

Sweden:

United Kingdom:

ê 1999/45/EC
(adapted)

è1 1272/2008 Art. 56 pt.2(l)

è2 1272/2008 Art. 56 pt. 3

è3 1272/2008 Art. 56 pt. 4

6.           Composition
of the preparation(s) defined in Heading 3
of Annex II to Regulation (EC) No 1907/2006.

7.           Classification of the
preparation(s) according to Article 6 of this Directive.

8.           Labelling of the preparation(s)
according to Article 10 of this Directive.

9.           Intended uses for the
preparation(s).

10.         Safety data sheet(s) conforming to
Regulation (EC) No 1907/2006.

PART
B

Lexicon
guide for establishing the alternative designations (generic names)

1.           Introductory note

The lexicon guide is based on the procedure for
the classification of dangerous substances (division of substances into
families) which appears in è1 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç.

Alternative designations to those based on this
guide may be used. However, in all cases the names chosen must provide enough
information to ensure the preparation can be handled without risk and that
necessary health and safety precautions can be taken in the workplace.

The families are defined in the following manner:

–
inorganic or organic substances whose properties
are identified by having a common chemical element as their chief
characteristic. The family name is derived from the name of the chemical
element. These families are identified as in è2 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç by the atomic
number of the chemical element (001 to 103),

–
organic substances whose properties are
identified by having a common functional group as their chief characteristics.

The family name is derived from the functional
group name.

These families are identified by the
conventional number found in è2 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç (601—650).

Sub-families bringing together substances with
a common specific character have been added in certain cases.

2.           Establishing the generic name

General principles

For the purposes of establishing the generic
name, the following general approach, involving two successive stages, is
adopted:

(i)      identification of the functional
groups and chemical elements present in the molecule;

(ii)     determination of the extent to which
account should be taken of the most important functional groups and chemical
elements.

The identified functional groups and elements
taken into account are the names of the families and sub-families set out in
point 3 in the form of a non-restrictive list.

3.           Division of substances into families and sub-families

Family No è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç || Families Sub-families

001 || Hydrogen compounds

|| Hydrides

002 || Helium compounds

003 || Lithium compounds

004 || Beryllium compounds

005 || Boron compounds

|| Boranes Borates

006 || Carbon compounds

|| Carbamates Inorganic carbon compounds Salts of hydrogen cyanide Urea and derivatives

007 || Nitrogen compounds

|| Quaternary ammonium compounds Acid nitrogen compounds Nitrates Nitrites

008 || Oxygen compounds

009 || Fluorine compounds

|| Inorganic fluorides

010 || Neon compounds

011 || Sodium compounds

012 || Magnesium compounds

|| Organometallic magnesium derivatives

013 || Aluminium compounds

|| Organometallic aluminium derivatives

014 || Silicon compounds

|| Silicones Silicates

015 || Phosphorus compounds

|| Acid phosphorus compounds Phosphonium compounds Phosphoric esters Phosphates Phosphites Phosphoramides and derivatives

016 || Sulphur compounds

|| Acid sulphur compounds Mercaptans Sulphates Sulphites

017 || Chlorine compounds

|| Chlorates Perchlorates

018 || Argon compounds

019 || Potassium compounds

020 || Calcium compounds

021 || Scandium compounds

022 || Titanium compounds

023 || Vanadium compounds

024 || Chromium compounds

|| Chromium VI compounds

025 || Manganese compounds

026 || Iron compounds

027 || Cobalt compounds

028 || Nickel compounds

029 || Copper compounds

030 || Zinc compounds

|| Organometallic zinc derivatives

031 || Gallium compounds

032 || Germanium compounds

033 || Arsenic compounds

034 || Selenium compounds

035 || Bromine compounds

036 || Krypton compounds

037 || Rubidium compounds

038 || Strontium compounds

039 || Yttrium compounds

040 || Zirconium compounds

041 || Niobium compounds

042 || Molybdenum compounds

043 || Technetium compounds

044 || Ruthenium compounds

045 || Rhodium compounds

046 || Palladium compounds

047 || Silver compounds

048 || Cadmium compounds

049 || Indium compounds

050 || Tin compounds

|| Organometallic tin derivatives

051 || Antimony compounds

052 || Tellurium compounds

053 || Iodine compounds

054 || Xenon compounds

055 || Caesium compounds

056 || Barium compounds

057 || Lanthanum compounds

058 || Cerium compounds

059 || Praseodymium compounds

060 || Neodymium compounds

061 || Promethium compounds

062 || Samarium compounds

063 || Europium compounds

064 || Gandolinium compounds

065 || Terbium compounds

066 || Dysprosium compounds

067 || Holmium compounds

068 || Erbium compounds

069 || Thulium compounds

070 || Ytterbium compounds

071 || Lutetium compounds

072 || Hafnium compounds

073 || Tantalum compounds

074 || Tungsten compounds

075 || Rhenium compounds

076 || Osmium compounds

077 || Iridium compounds

078 || Platinum compounds

079 || Gold compounds

080 || Mercury compounds

|| Organometallic mercury derivatives

081 || Thallium compounds

082 || Lead compounds

|| Organometallic lead derivatives

083 || Bismuth compounds

084 || Polonium compounds

085 || Astate compounds

086 || Radon compounds

087 || Francium compounds

088 || Radium compounds

089 || Actinium compounds

090 || Thorium compounds

091 || Protactinium compounds

092 || Uranium compounds

093 || Neptunium compounds

094 || Plutonium compounds

095 || Americium compounds

096 || Curium compounds

097 || Berkelium compounds

098 || Californium compounds

099 || Einsteinium compounds

100 || Fermium compounds

101 || Mendelevium compounds

102 || Nobelium compounds

103 || Lawrencium compounds

601 || Hydrocarbons

|| Aliphatic hydrocarbons Aromatic hydrocarbons Alicyclic hydrocarbons Polycyclic aromatic hydrocarbons (PAH)

602 || Halogenated hydrocarbons (*)

|| Halogenated aliphatic hydrocarbons (*) Halogenated aromatic hydrocarbons (*) Halogenated alicyclic hydrocarbons (*)

(*)            Specify according to the family corresponding to halogen.

603 || Alcohols and derivatives

|| Aliphatic alcohols Aromatic alcohols Alicyclic alcohols Alcanolamines Epoxy derivatives Ethers Glycolethers

|| || Glycols and polyols

604 || Phenols and derivatives

|| Halogenated phenol derivatives (*)

(*)               Specify according to the family corresponding to halogen.

605 || Aldehydes and derivatives

|| Aliphatic aldehydes Aromatic aldehydes Alicyclic aldehydes Aliphatic acetals Aromatic acetals Alicyclic acetals

606 || Ketones and derivatives

|| Aliphatic ketones Aromatic ketones (*) Alicyclic ketones

(*)               Quinones included.

607 || Organic acids and derivatives

|| Aliphatic acids Halogenated aliphatic acids (*) Aromatic acids Halogenated aromatic acids (*) Alicyclic acids Halogenated alicyclic acids (*) Aliphatic acid anhydrides Halogenated aliphatic acid anhydrides (*) Aromatic acid anhydrides Halogenated aromatic acid anhydrides (*) Alicyclic acid anhydrides Halogenated alicyclic acid anhydrides (*) Salts of aliphatic acid Salts of halogenated aliphatic acid (*) Salts of aromatic acid Salts of halogenated aromatic acid (*) Salts of alicyclic acid Salts of halogenated alicyclic acid (*) Esters of aliphatic acid Esters of halogenated alicyclic acid (*) Esters of aromatic acid Esters of halogenated aromatic acid (*) Esters of alicyclic acid Esters of halogenated alicyclic acid (*) Esters of glycol ether Acrylates Methacrylates Lactones Acyl halogenides

(*)               Specify according to the family corresponding to halogen.

608 || Nitriles and derivatives

609 || Nitro compounds

610 || Chlornitrated compounds

611 || Azoxy and azo compounds

612 || Amine compounds

|| Aliphatic amines and derivatives Alicyclic amines and derivatives Aromatic amines and derivatives Aniline and derivatives Benzidine and derivatives

613 || Heterocyclic bases and derivatives

|| Benzimidazole and derivatives Imidazol and derivatives Pyrethrinoids Quinoline and derivatives Triazine and derivatives Triazole and derivatives

614 || Glycosides and alkaloids

|| Alkaloid and derivatives Glycosides and derivatives

615 || Cyanates and isocyanates

|| Cyanates Isocyanates

616 || Amides and derivatives

|| Acetamide and derivatives Anilides

617 || Organic peroxides

647 || Enzymes

648 || Complex coal derivatives

|| Acid extract Alkaline extract Anthracene oil Anthracene oil extract residue Anthracene oil fraction Carbolic oil Carbolic oil extract residue Coal liquids, liquid solvent extraction Coal liquids, liquid solvent extraction solvents Coal oil Coal tar Coal tar extract Coal tar solids residue Coke (coal tar) low temperature, high temperature pitch Coke (coal tar), high temperature pitch Coke (coal tar), mixed coal high temperature pitch Crude benzole Crude phenols Crude tar bases Distillate bases Distillate phenols Distillates Distillates (coal), liquid solvent extraction, primary Distillates (coal), solvent extraction, hydrocracked Distillates (coal), solvent extraction, hydrocracked hydrogenated middle Distillates (coal), solvent extraction, hydrocracked middle Extract residues (coal), low temperature coal tar alkaline Fresh oil Fuels, diesel, coal solvent extraction, hydrocracked, hydrogenated Fuels, jet aircraft, coal solvent extraction, hydrocracked, hydrogenated Gasoline, coal solvent extraction, hydrocracked naphtha Heat treatment products Heavy anthracene oil Heavy anthracene oil redistillate Light oil Light oil extract residues, high boiling Light oil extract residues, intermediate boiling Light oil extract residues, low boiling Light oil redistillate, high boiling Light oil redistillate, intermediate boiling Light oil redistillate, low boiling Methylnaphthalene oil Methylnaphthalene oil extract residue Naphtha (coal), solvent extraction, hydrocracked Naphthalene oil Naphthalene oil extract residue Naphthalene oil redistillate Pitch Pitch redistillate Pitch residue Pitch residue, heat treated Pitch residue, oxidised Pyrolysis products Redistillates Residues (coal), liquid solvent extractions Tar brown coal Tar brown coal, low temperature Tar oil, high boiling Tar oil, intermediate boiling Wash oil Wash oil extract residue Wash oil redistillate

649 || Complex oil derivatives

|| Crude oil Petroleum gas Low boiling point naphtha Low boiling point modified naphtha Low boiling point cat-cracked naphtha Low boiling point cat-reformed naphtha Low boiling point thermally cracked naphtha Low boiling point hydrogen treated naphtha Low boiling point naphtha — unspecified Straight-run kerosine Kerosine — unspecified Cracked gas oil Gas oil — unspecified Heavy fuel oil Grease Unrefined or mildly refined base oil Base oil — unspecified Distillate aromatic extract Distillate aromatic extract (treated) Foots oil Slack wax Petrolatum

650 || Various substances

|| Do not use this family. Instead, use the families or sub-families mentioned above.

4.           Practical application:

After having conducted a search to see if the
substance belongs to one or more families or sub-families on the list, the
generic name can be established in the following way:

4.1.        If the name of a family or
sub-family is sufficient to characterise the chemical elements or important
functional groups, this name will be chosen as the generic name.

Examples:

–
1,4 dihydroxybenzen

family 604 || : || phenols and derivatives

generic name || : || phenol derivatives

–
butanol

family 603 || : || alcohols and derivatives

sub-family || : || aliphatic alcohols

generic name || : || aliphatic alcohol

–
2-Isopropoxyethanol

family 603 || : || alcohols and derivatives

sub-family || : || glycolethers

generic name || : || glycolether

–
methacrylate

family 607 || : || organic acids and derivatives

sub-family || : || acrylates

generic name || : || acrylate

4.2.        If the name of a family or
sub-family is not sufficient to characterise the chemical elements of important
functional groups, the generic name will be a combination of the corresponding
different family or sub-family names:

Examples:

–
chlorobenzene

family 602 || : || halogenated hydrocarbons

sub-family || : || halogenated aromatic hydrocarbons

family 017 || : || chlorine compounds

generic name || : || chlorinated aromatic hydrocarbon

–
2,3,6-trichlorophenylacetic acid

family 607 || : || organic acids

sub-family || : || halogenated aromatic acids

family 017 || : || chlorine compounds

generic name || : || chlorinated aromatic acid

–
1-chloro-1-nitropropane

family 610 || : || chloronitrated derivatives

family 601 || : || hydrocarbons

sub-family || : || aliphatic hydrocarbons

generic name || : || chlorinated aliphatic hydrocarbon

–
tetrapropyl dithiopyrophosphate

family 015 || : || phosphorus compounds

sub-family || : || phosphoric esters

family 016 || : || sulphur compounds

generic name || : || thiophosphoric ester

NB:   In the
case of certain elements, notably metals, the name of the family or sub‑family
may be indicated by the words‘organic’ or ‘inorganic’.

Examples:

–
dimercury chloride

family 080 || : || mercury compounds

generic name || : || inorganic mercury compound

–
barium acetate

family 056 || : || barium compounds

generic name || : || organic barium compound

–
ethyl nitrite

family 007 || : || nitrogen compounds

sub-family || : || nitrites

generic name || : || organic nitrite

–
sodium hydrosulphite

family 016 || : || sulphur compounds

generic name || : || inorganic sulphur compound

(The examples cited are substances taken from è3 Part 3 of Annex VI to Regulation (EC)
No 1272/2008 ç in respect of
which requests for confidentiality may be submitted).

_____________

ANNEX VII

PREPARATIONS COVERED BY ARTICLE
12(2)

Preparations as specified by point 9.3 of
Annex VI to Directive 67/548/EEC.

_____________

é

ANNEX VIII

Part A

Repealed Directive with list of its
successive amendments
(referred to in Article 22)

Directive 1999/45/EC of the European Parliament and of the Council (OJ L 200, 30.7.1999, p. 1) || ||

|| Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p. 5) ||

|| Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) || Only point 90 of Annex III

|| Council Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35) || Only as regards the reference to Directive 1999/45/EC in Article 1 and point I.B of the Annex

|| Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12) ||

|| Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81) || Only as regards the reference to Directive 1999/45/EC in Article 1 and section G of the Annex

|| Regulation (EC) No 1907/2006 of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 1) || Only Article 140

|| Regulation (EC) No 1137/2008 of the European Parliament and of the Council (OJ L 311, 21.11.2008, p. 1) || Only point 3.5 of the Annex

|| Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L 353, 31.12.2008, p. 1) || Only Article 56

Part B

List
of time-limits for transposition into national law
(referred to in Article 22)

Directive || Time-limit for transposition

1999/45/EC || 30 July 2002

2001/60/EC || 30 July 2002

2004/66/EC || 1 May 2004

2006/8/EC || 1 March 2007

2006/96/EC || 1 January 2007

_____________

ANNEX IX

Correlation Table

Directive 1999/45/EC || This Directive

Article 1(1), introductory wording || Article 1(1)

Article 1(1), first indent || Article 1(1)

Article 1(1), second indent || Article 1(1)

Article 1(1), last wording || Article 1(1)

Article 1(2), introductory wording || Article 1(2), introductory wording

Article 1(2), first indent || Article 1(2)(a)

Article 1(2), second indent || Article 1(2)(b)

Article 1(3), introductory wording || Article 1(3)

Article 1(3), first indent || Article 1(3)

Article 1(3), second indent || Article 1(3)

Article 1(3), third indent || –

Article 1(3), last wording || Article 1(3)

Article 1(4) || Article 1(4)

Article 1(5) || Article 1(5)

Article 1(6), introductory wording || Article 1(6), introductory wording

Article 1(6), first indent || Article 1(6)(a)

Article 1(6), second indent || Article 1(6)(b)

Article 2(1), introductory wording || Article 2(1), introductory wording

Article 2(1)(a), (b) and (c) || Article 2(1)(a), (b) and (c)

Article 2(1)(d) || –

Article 2(1)(e) || Article 2(1)(d)

Article 2(1)(f) || Article 2(1)(e)

Article 2(1)(g) || Article 2(1)(f)

Article 2(1)(h) || Article 2(1)(g)

Article 2(2), introductory wording || Article 2(2), introductory wording

Article 2(2)(a), (b) and (c) || Article 2(2)(a), (b) and (c)

Article 2(2)(d), introductory wording || Article 2(2)(d), introductory wording

Article 2(2)(d), first indent || Article 2(2)(d)(i)

Article 2(2)(d), second indent || Article 2(2)(d)(ii)

Article 2(2)(d), third indent || Article 2(2)(d)(iii)

Article 2(2)(d), fourth indent || Article 2(2)(d)(iv)

Article 2(2)(e) to (o) || Article 2(2)(e) to (o)

Article 3(1), first subparagraph, introductory wording || Article 3(1), first subparagraph, introductory wording

Article 3(1), first subparagraph, first indent || Article 3(1), first subparagraph, point (a)

Article 3(1), first subparagraph, second indent || Article 3(1), first subparagraph, point (b)

Article 3(1), first subparagraph, third indent || Article 3(1), first subparagraph, point (c)

Article 3(1), second and third subparagraphs || Article 3(1), second and third subparagraphs

Article 3(2), introductory wording || Article 3(2), introductory wording

Article 3(2), first indent || Article 3(2)(a)

Article 3(2), second indent || –

Article 3(2), third indent || Article 3(2)(b)

Article 3(2), fourth indent || –

Article 3(2), fifth indent || –

Article 3(2), sixth indent || –

Article 3(2), last wording || Article 3(2), introductory wording

Article 3(3) || Article 3(3)

Article 4 || Article 4

Article 5(1) || Article 5(1)

Article 5(2), first introductory wording || Article 5(2), introductory wording

Article 5(2), second introductory wording || Article 5(2), introductory wording

Article 5(2), first indent || Article 5(2)(a)

Article 5(2), second indent || Article 5(2)(b)

Article 5(2), third indent || Article 5(2)(c)

Article 5(3), (4) and (5) || Article 5(3), (4) and (5)

Article 6(1) and (2) || Article 6(1) and (2)

Article 6(3), introductory wording || Article 6(3), introductory wording

Article 6(3), first indent, first part || Article 6(3), introductory wording

Article 6(3), first indent, second part || Article 6(3), first indent

Article 6(3), second indent || Article 6(3), second indent

Article 6(3), third indent || Article 6(3), third indent

Article 6(4) || Article 6(4)

Article 7 || Article 7

Article 8(1) and (2) || Article 8(1) and (2)

Article 8(3), introductory wording || Article 8(3), introductory wording

Article 8(3), first indent || Article 8(3)(a)

Article 8(3), second indent || Article 8(3)(b)

Article 8(3), third indent || Article 8(3)(c)

Article 8(4) || Article 8(4)

Article 9, point 1, introductory wording || Article 9(1), first subparagraph, introductory wording

Article 9, point 1.1, introductory wording || Article 9(1), first subparagraph, point (a), introductory wording

Article 9, point 1.1, first indent || Article 9(1), first subparagraph, point (a)(i)

Article 9, point 1.1, second indent || Article 9(1), first subparagraph, point (a)(ii)

Article 9, point 1.1, third indent || Article 9(1), first subparagraph, point (a)(iii)

Article 9, point 1.1, fourth indent || Article 9(1), first subparagraph, point (a)(iv)

Article 9, point 1.2, introductory wording || Article 9(1), first subparagraph, point (b), introductory wording

Article 9, point 1.2, first indent || Article 9(1), first subparagraph, point (b)(i)

Article 9, point 1.2, second indent || Article 9(1), first subparagraph, point (b)(ii)

Article 9, point 1.3, first subparagraph, introductory wording || Article 9(1), first subparagraph, point (c), introductory wording

Article 9, point 1.3, first subparagraph, first indent || Article 9(1), first subparagraph, point (c)(i)

Article 9, point 1.3, first subparagraph, second indent || Article 9(1), first subparagraph, point (c)(ii)

Article 9, point 1.3, second subparagraph || Article 9(1), second subparagraph

Article 9(2) || Article 9(2)

Article 10, point 1.1, introductory wording || Article 10(1), introductory wording

Article 10, point 1.1(a) || Article 10(1)(a)

Article 10, point 1.1(b) || Article 10(1)(b)

Article 10, point 1.2 || Article 10(2)

Article 10, point 2, introductory wording || Article 10(3), introductory wording

Article 10, point 2.1 || Article 10(3)(a)

Article 10, point 2.2 || Article 10(3)(b)

Article 10, point 2.3, introductory wording || Article 10(3)(c), introductory wording

Article 10, point 2.3.1 || Article 10(3)(c)(i)

Article 10, point 2.3.2 || Article 10(3)(c)(ii)

Article 10, point 2.3.3, first subparagraph, introductory wording || Article 10(3)(c)(iii), first subparagraph, introductory wording

Article 10, point 2.3.3, first subparagraph, first indent || Article 10(3)(c)(iii), first subparagraph, first indent

Article 10, point 2.3.3, first subparagraph, second indent || Article 10(3)(c)(iii), first subparagraph, second indent

Article 10, point 2.3.3, first subparagraph, third indent || Article 10(3)(c)(iii), first subparagraph, third indent

Article 10, point 2.3.3, first subparagraph, fourth indent || Article 10(3)(c)(iii), first subparagraph, fourth indent

Article 10, point 2.3.3, first subparagraph, fifth indent || Article 10(3)(c)(iii), first subparagraph, fifth indent

Article 10, point 2.3.3, first subparagraph, sixth indent || Article 10(3)(c)(iii), first subparagraph, sixth indent

Article 10, point 2.3.3, first subparagraph, last wording || Article 10(3)(c)(iii), first subparagraph, introductory wording

Article 10, point 2.3.3, second subparagraph || Article 10(3)(c)(iii), second subparagraph

Article 10, point 2.3.4, introductory wording || Article 10(3)(c)(iv), introductory wording

Article 10, point 2.3.4, first indent || Article 10(3)(c)(iv), first indent

Article 10, point 2.3.4, second indent || Article 10(3)(c)(iv), second indent

Article 10, point 2.3.4, third indent || Article 10(3)(c)(iv), third indent

Article 10, point 2.3.4, fourth indent || Article 10(3)(c)(iv), fourth indent

Article 10, point 2.3.4, fifth indent || Article 10(3)(c)(iv), fifth indent

Article 10, point 2.3.4, sixth indent || Article 10(3)(c)(iv), sixth indent

Article 10, point 2.3.4, seventh indent || Article 10(3)(c)(iv), seventh indent

Article 10, point 2.3.4, last wording || Article 10(3)(c)(iv), introductory wording

Article 10, point 2.3.5 || Article 10(3)(c)(v)

Article 10, point 2.4, first subparagraph || Article 10(3)(d), first subparagraph

Article 10, point 2.4, second subparagraph, introductory wording || Article 10(3)(d), second subparagraph, introductory wording

Article 10, point 2.4, second subparagraph, first indent || Article 10(3)(d), second subparagraph, point (i)

Article 10, point 2.4, second subparagraph, second indent || Article 10(3)(d), second subparagraph, point (ii)

Article 10, point 2.4, second subparagraph, third indent || Article 10(3)(d), second subparagraph, point (iii)

Article 10, point 2.4, second subparagraph, fourth indent || Article 10(3)(d), second subparagraph, point (iv)

Article 10, point 2.4, third subparagraph || Article 10(3)(d), third subparagraph

Article 10, point 2.5 || Article 10(3)(e)

Article 10, point 2.6 || Article 10(3)(f)

Article 10, point 2.7 || Article 10(3)(g)

Article 10, point 3 || Article 10(4)

Article 10, point 4, introductory wording || Article 10(5), introductory wording

Article 10, point 4, first indent || Article 10(5)(a)

Article 10, point 4, second indent || Article 10(5)(b)

Article 10, point 5 || Article 10(6)

Article 11(1) to (5) || Article 11(1) to (5)

Article 11(6), introductory wording || Article 11(6), introductory wording

Article 11(6)(a) || Article 11(6)(a)

Article 11(6)(b), first subparagraph, introductory wording || Article 11(6)(b), first subparagraph, introductory wording

Article 11(6)(b), first subparagraph, first indent || Article 11(6)(b), first subparagraph, point (i)

Article 11(6)(b), first subparagraph, second indent || Article 11(6)(b), first subparagraph, point (ii)

Article 11(6)(b), second subparagraph || Article 11(6)(b), second subparagraph

Articles 12 and 13 || Articles 12 and 13

Article 15 || Article 14, first to fifth paragraphs

– || Article 14, sixth paragraph

Article 16 || Article 15

Article 17 || Article 16

Article 18 || Article 17

Article 19 || Article 18

Article 20 || Article 19

Article 20a(1) and (2) || Article 21

Article 20a(3) || –

– || Article 20

– || Article 22

Article 21 || –

Article 22 || –

Article 23 || Article 23

Article 24 || Article 24

Annex I–VII || Annex I–VII

Annex VIII || –

Annex IX || –

– || Annex VIII

– || Annex IX

_____________

[1]               COM(87) 868 PV.

[2]               OJ L 200, 30.7.1999, p. 1.

[3]               See Annex VIII, Part A to this proposal.

[4]               OJ C [...], [...], p. [...].

[5]               OJ C [...], [...], p. [...].

[6]               OJ L 200, 30.7.1999, p. 1.

[7]               See Annex VIII, Part A.

[8]               OJ L Ö 276,
20.10.2010, p. 33 Õ.

[9]               OJ L 396,
30.12.2006, p. 1.

[10]             OJ L Ö 309, 24.11.2009, p. 1 Õ.

[11]             OJ L 123, 24.4.1998, p. 1.

[12]             OJ 196, 16.8.1967, p. 1.

[13]             OJ
L 396, 30.12.2006, p. 850.

[14]             OJ L 353, 31.12.2008, p. 1.

[15]             OJ L 225, 21.8.2001, p. 1.

[16]             OJ L 355, 30.12.1998, p. 1.

[17]             OJ L 154, 5.6.1992, p. 1.

[18]             OJ L 110, 4.5.1993, p. 20.

[19]             OJ L 55, 28.2.2011, p. 13.

[20]             OJ L 311, 28.11.2001, p. 1.

[21]             OJ L 311, 28.11.2001, p. 67.

[22]             OJ L 262, 27.9.1976, p. 169.

[23]             OJ L 312, 22.11.2008, p. 3.

[24]             OJ L 159, 29.6.1996, p. 1.

[25]             OJ L 142, 31.5.2008, p. 1.

[26]             OJ L 147, 9.6.1975, p. 40.

[27]             OJ L 155, 11.6.2011, p. 1.

[28]             OJ L 155, 11.6.2011, p. 67.

[29]             OJ L 50, 20.2.2004, p. 44.

[30]             OJ L 155, 11.6.2011, p. 176.

[31]             OJ L 144, 4.6.1997, p. 19.